The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical in this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Plan work and supply needs. Communicate and explain work instructions. Train or ensure training of staff on procedures (as the Job Qualified Trainer). Assign workstations, lead, and coordinate team activities. Troubleshoot technical issues and make necessary adjustments (with support services if needed). Operate production lines when permanent operators are absent. Maintain team cohesion and motivation. Propose and implement improvements in work organization. Review production packaging records before Quality Assurance review. Serve as the main contact point during audits in the area. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Promote safe behaviors and practices, verify EHS rules are implemented and followed. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Preferred Qualifications: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Experience / Education A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimum guidance. Languages: English Knowledge / Skills / Abilities: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Natural leadership, able to share expertise, technical knowledge, and experience to develop the team. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting. Proactive in proposing and implementing work organization improvements. Strong problem-solving skills. Able to communicate activity progress and issues encountered. Capable of leading continuous improvement projects with support departments. Strong sense of responsibility. Ability to manage projects. Comfortable giving presentations to groups. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/04/2025
Full time
The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical in this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Plan work and supply needs. Communicate and explain work instructions. Train or ensure training of staff on procedures (as the Job Qualified Trainer). Assign workstations, lead, and coordinate team activities. Troubleshoot technical issues and make necessary adjustments (with support services if needed). Operate production lines when permanent operators are absent. Maintain team cohesion and motivation. Propose and implement improvements in work organization. Review production packaging records before Quality Assurance review. Serve as the main contact point during audits in the area. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Promote safe behaviors and practices, verify EHS rules are implemented and followed. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Preferred Qualifications: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Experience / Education A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimum guidance. Languages: English Knowledge / Skills / Abilities: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Natural leadership, able to share expertise, technical knowledge, and experience to develop the team. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting. Proactive in proposing and implementing work organization improvements. Strong problem-solving skills. Able to communicate activity progress and issues encountered. Capable of leading continuous improvement projects with support departments. Strong sense of responsibility. Ability to manage projects. Comfortable giving presentations to groups. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
The Senior Cost Accountant will be responsible for managing, analyzing, and reporting cost information to support decision-making within our pharmaceutical manufacturing operations. This role will focus on standard costing, cost variance analysis, inventory valuation, capex/fixed asset maintenance, and financial reporting to ensure compliance with company policies, regulatory standards, and industry's best practices. The individual will work closely with operations, supply chain, and finance teams to optimize cost structures and drive continuous improvement in cost control processes. Lead calculation of annual standard costs and monitor the inventory revaluation process. Analyze standard costs and perform manufacturing variances analysis to support decision making. Assist in developing budgets, forecasts, and financial plans for manufacturing operations. Perform inventory valuation and reconciliation activities, cycle counts, and physical inventory oversight to ensure accuracy of raw materials, WIP, and finished goods balances. Partner with operations and procurement to analyze cost reduction opportunities and recommend process improvements , BOM/routing accuracy, new product costing, and process improvements. Serve as liaison between Finance and Manufacturing/Operations to ensure accurate tracking of production costs, routings, and BOM accuracy. Support product costing for new product launches, capital projects, and process changes. Prepare journal entries, account reconciliations, and financial schedules. Assist with internal/external audits, ensuring adherence to SOX controls and corporate policies. Collaborate with cross-functional teams to ensure compliance with GMP, FDA, and other regulatory requirements for cost accounting data. Key owner of Capex & Fixed Asset modules Prepare actual vs. budget capex reporting and cash forecasting Support SAP implementation process & become an SME in related Cost areas. Develop and maintain cost accounting policies, procedures, and documentation . Other ad hoc analysis as requested Experience / Education: Bachelor's degree in Accounting, Finance, or related field. 5 years of accounting experience, with at least 2 years in cost accounting experience in pharma, biotechnology, or manufacturing industry required. Knowledge of standard costing, cost analysis, and inventory control in a GMP-regulated environment. Knowledge of SAP FI/CO or similar ERP is needed. Experience with Microsoft Office products Ability to work independently and collaboratively in cross-functional teams. Detail-oriented with strong organizational and time-management skills. Startup background & ability to assist in multiple roles will be helpful. Cost Modeling & What-If modeling Travel Requirements: On-site location / Minimal travel required. Physical Requirements: Able to work in environment with variable noise levels Ability to stand/sit/walk for long periods of time Ability to crouch, bend, twist, & reach Ability to push/pull/lift 10 lbs routinely/often/occasionally Clarity of Vision Must be able to perform activities with repetitive motions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/04/2025
Full time
The Senior Cost Accountant will be responsible for managing, analyzing, and reporting cost information to support decision-making within our pharmaceutical manufacturing operations. This role will focus on standard costing, cost variance analysis, inventory valuation, capex/fixed asset maintenance, and financial reporting to ensure compliance with company policies, regulatory standards, and industry's best practices. The individual will work closely with operations, supply chain, and finance teams to optimize cost structures and drive continuous improvement in cost control processes. Lead calculation of annual standard costs and monitor the inventory revaluation process. Analyze standard costs and perform manufacturing variances analysis to support decision making. Assist in developing budgets, forecasts, and financial plans for manufacturing operations. Perform inventory valuation and reconciliation activities, cycle counts, and physical inventory oversight to ensure accuracy of raw materials, WIP, and finished goods balances. Partner with operations and procurement to analyze cost reduction opportunities and recommend process improvements , BOM/routing accuracy, new product costing, and process improvements. Serve as liaison between Finance and Manufacturing/Operations to ensure accurate tracking of production costs, routings, and BOM accuracy. Support product costing for new product launches, capital projects, and process changes. Prepare journal entries, account reconciliations, and financial schedules. Assist with internal/external audits, ensuring adherence to SOX controls and corporate policies. Collaborate with cross-functional teams to ensure compliance with GMP, FDA, and other regulatory requirements for cost accounting data. Key owner of Capex & Fixed Asset modules Prepare actual vs. budget capex reporting and cash forecasting Support SAP implementation process & become an SME in related Cost areas. Develop and maintain cost accounting policies, procedures, and documentation . Other ad hoc analysis as requested Experience / Education: Bachelor's degree in Accounting, Finance, or related field. 5 years of accounting experience, with at least 2 years in cost accounting experience in pharma, biotechnology, or manufacturing industry required. Knowledge of standard costing, cost analysis, and inventory control in a GMP-regulated environment. Knowledge of SAP FI/CO or similar ERP is needed. Experience with Microsoft Office products Ability to work independently and collaboratively in cross-functional teams. Detail-oriented with strong organizational and time-management skills. Startup background & ability to assist in multiple roles will be helpful. Cost Modeling & What-If modeling Travel Requirements: On-site location / Minimal travel required. Physical Requirements: Able to work in environment with variable noise levels Ability to stand/sit/walk for long periods of time Ability to crouch, bend, twist, & reach Ability to push/pull/lift 10 lbs routinely/often/occasionally Clarity of Vision Must be able to perform activities with repetitive motions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations across Asia, North America and Europe. As an innovative Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Controls) solutions from preclinical to commercial. STA Pharmaceuticals is constructing a new greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware. The facility will be a four (4) building campus with 460,000 sq. ft. of office, laboratory, and manufacturing spaces. The facility is currently under construction with a planned first phase completion date in 2026. As the project progresses, we are creating the role of Site Administration Support Lead to support project execution and lead ongoing site support and administration functions. We are seeking an experienced professional with manufacturing site administration and support experience, as well as outstanding project and process management, and communication skills. This position will report to the Site Head of STA Drug Product Manufacturing Middletown. Throughout the site construction project phase, the Project Team operates in a start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical at this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for administrative support to the Project Team members, demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits and team agendas strategically, including the coordination of senior executives' site visits. Support the design and allocation of the temporary project office and future permanent office space. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for site office supplies, workspaces, transportation, facility cleaning and housekeeping, security, catering, and other site services. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. Support the design and creation of the site administrative support process. Manage resources according to site priorities and anticipate future service needs. Demonstrate a commitment to safety and ensure conformance to EHS (Environmental, Health, and Safety) expectations, including fire safety. Manage and support senior management's offices on the site. Coordinate site-level initiatives, events, and activities. Be the champion and support for a continuous improvement culture across the site and benchmark best practices both internally and externally. Perform other related duties as assigned. Critical Skills and Capabilities Adaptability to a fast-paced, start-up-like environment, with a willingness to embrace changes and uncertainties. Flexibility and proactiveness, with the ability to take initiative. Strong organizational skills, able to handle multiple priorities and deadlines. Excellent skills with Microsoft Office suites, particularly Outlook, Excel, PowerPoint, and Word. Excellent communication, collaboration, and relationship-building skills. A strong spirit of teamwork. Outstanding problem-solving skills. A minimum of a bachelor's or associate degree with experience in administration support, ideally in a manufacturing site. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team is preferred. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimal guidance. Languages: English An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/04/2025
Full time
STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations across Asia, North America and Europe. As an innovative Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Controls) solutions from preclinical to commercial. STA Pharmaceuticals is constructing a new greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware. The facility will be a four (4) building campus with 460,000 sq. ft. of office, laboratory, and manufacturing spaces. The facility is currently under construction with a planned first phase completion date in 2026. As the project progresses, we are creating the role of Site Administration Support Lead to support project execution and lead ongoing site support and administration functions. We are seeking an experienced professional with manufacturing site administration and support experience, as well as outstanding project and process management, and communication skills. This position will report to the Site Head of STA Drug Product Manufacturing Middletown. Throughout the site construction project phase, the Project Team operates in a start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical at this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for administrative support to the Project Team members, demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits and team agendas strategically, including the coordination of senior executives' site visits. Support the design and allocation of the temporary project office and future permanent office space. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for site office supplies, workspaces, transportation, facility cleaning and housekeeping, security, catering, and other site services. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. Support the design and creation of the site administrative support process. Manage resources according to site priorities and anticipate future service needs. Demonstrate a commitment to safety and ensure conformance to EHS (Environmental, Health, and Safety) expectations, including fire safety. Manage and support senior management's offices on the site. Coordinate site-level initiatives, events, and activities. Be the champion and support for a continuous improvement culture across the site and benchmark best practices both internally and externally. Perform other related duties as assigned. Critical Skills and Capabilities Adaptability to a fast-paced, start-up-like environment, with a willingness to embrace changes and uncertainties. Flexibility and proactiveness, with the ability to take initiative. Strong organizational skills, able to handle multiple priorities and deadlines. Excellent skills with Microsoft Office suites, particularly Outlook, Excel, PowerPoint, and Word. Excellent communication, collaboration, and relationship-building skills. A strong spirit of teamwork. Outstanding problem-solving skills. A minimum of a bachelor's or associate degree with experience in administration support, ideally in a manufacturing site. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team is preferred. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimal guidance. Languages: English An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations across Asia, North America and Europe. As an innovative Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Controls) solutions from preclinical to commercial. STA Pharmaceuticals is constructing a new greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware. The facility will be a four (4) building campus with 460,000 sq. ft. of office, laboratory, and manufacturing spaces. The facility is currently under construction with a planned first phase completion date in 2026. As the project progresses, we are creating the role of Site Administration Support Lead to support project execution and lead ongoing site support and administration functions. We are seeking an experienced professional with manufacturing site administration and support experience, as well as outstanding project and process management, and communication skills. This position will report to the Site Head of STA Drug Product Manufacturing Middletown. Throughout the site construction project phase, the Project Team operates in a start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical at this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for administrative support to the Project Team members, demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits and team agendas strategically, including the coordination of senior executives' site visits. Support the design and allocation of the temporary project office and future permanent office space. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for site office supplies, workspaces, transportation, facility cleaning and housekeeping, security, catering, and other site services. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. Support the design and creation of the site administrative support process. Manage resources according to site priorities and anticipate future service needs. Demonstrate a commitment to safety and ensure conformance to EHS (Environmental, Health, and Safety) expectations, including fire safety. Manage and support senior management's offices on the site. Coordinate site-level initiatives, events, and activities. Be the champion and support for a continuous improvement culture across the site and benchmark best practices both internally and externally. Perform other related duties as assigned. Critical Skills and Capabilities Adaptability to a fast-paced, start-up-like environment, with a willingness to embrace changes and uncertainties. Flexibility and proactiveness, with the ability to take initiative. Strong organizational skills, able to handle multiple priorities and deadlines. Excellent skills with Microsoft Office suites, particularly Outlook, Excel, PowerPoint, and Word. Excellent communication, collaboration, and relationship-building skills. A strong spirit of teamwork. Outstanding problem-solving skills. A minimum of a bachelor's or associate degree with experience in administration support, ideally in a manufacturing site. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team is preferred. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimal guidance. Languages: English An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/04/2025
Full time
STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations across Asia, North America and Europe. As an innovative Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Controls) solutions from preclinical to commercial. STA Pharmaceuticals is constructing a new greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware. The facility will be a four (4) building campus with 460,000 sq. ft. of office, laboratory, and manufacturing spaces. The facility is currently under construction with a planned first phase completion date in 2026. As the project progresses, we are creating the role of Site Administration Support Lead to support project execution and lead ongoing site support and administration functions. We are seeking an experienced professional with manufacturing site administration and support experience, as well as outstanding project and process management, and communication skills. This position will report to the Site Head of STA Drug Product Manufacturing Middletown. Throughout the site construction project phase, the Project Team operates in a start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical at this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for administrative support to the Project Team members, demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits and team agendas strategically, including the coordination of senior executives' site visits. Support the design and allocation of the temporary project office and future permanent office space. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for site office supplies, workspaces, transportation, facility cleaning and housekeeping, security, catering, and other site services. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. Support the design and creation of the site administrative support process. Manage resources according to site priorities and anticipate future service needs. Demonstrate a commitment to safety and ensure conformance to EHS (Environmental, Health, and Safety) expectations, including fire safety. Manage and support senior management's offices on the site. Coordinate site-level initiatives, events, and activities. Be the champion and support for a continuous improvement culture across the site and benchmark best practices both internally and externally. Perform other related duties as assigned. Critical Skills and Capabilities Adaptability to a fast-paced, start-up-like environment, with a willingness to embrace changes and uncertainties. Flexibility and proactiveness, with the ability to take initiative. Strong organizational skills, able to handle multiple priorities and deadlines. Excellent skills with Microsoft Office suites, particularly Outlook, Excel, PowerPoint, and Word. Excellent communication, collaboration, and relationship-building skills. A strong spirit of teamwork. Outstanding problem-solving skills. A minimum of a bachelor's or associate degree with experience in administration support, ideally in a manufacturing site. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team is preferred. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimal guidance. Languages: English An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical in this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Plan work and supply needs. Communicate and explain work instructions. Train or ensure training of staff on procedures (as the Job Qualified Trainer). Assign workstations, lead, and coordinate team activities. Troubleshoot technical issues and make necessary adjustments (with support services if needed). Operate production lines when permanent operators are absent. Maintain team cohesion and motivation. Propose and implement improvements in work organization. Review production packaging records before Quality Assurance review. Serve as the main contact point during audits in the area. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Promote safe behaviors and practices, verify EHS rules are implemented and followed. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Preferred Qualifications: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Experience / Education A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimum guidance. Languages: English Knowledge / Skills / Abilities: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Natural leadership, able to share expertise, technical knowledge, and experience to develop the team. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting. Proactive in proposing and implementing work organization improvements. Strong problem-solving skills. Able to communicate activity progress and issues encountered. Capable of leading continuous improvement projects with support departments. Strong sense of responsibility. Ability to manage projects. Comfortable giving presentations to groups. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/04/2025
Full time
The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical in this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Plan work and supply needs. Communicate and explain work instructions. Train or ensure training of staff on procedures (as the Job Qualified Trainer). Assign workstations, lead, and coordinate team activities. Troubleshoot technical issues and make necessary adjustments (with support services if needed). Operate production lines when permanent operators are absent. Maintain team cohesion and motivation. Propose and implement improvements in work organization. Review production packaging records before Quality Assurance review. Serve as the main contact point during audits in the area. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Promote safe behaviors and practices, verify EHS rules are implemented and followed. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Preferred Qualifications: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Experience / Education A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimum guidance. Languages: English Knowledge / Skills / Abilities: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Natural leadership, able to share expertise, technical knowledge, and experience to develop the team. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting. Proactive in proposing and implementing work organization improvements. Strong problem-solving skills. Able to communicate activity progress and issues encountered. Capable of leading continuous improvement projects with support departments. Strong sense of responsibility. Ability to manage projects. Comfortable giving presentations to groups. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
This role will design, develop, optimize, and support GMP drug product manufacturing and packaging process, including equipment, facilities, and control systems at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed. Implementing and maintaining manufacturing process automation and control systems. Participate as a member of cross functional teams in completion of system impact evaluations and system risk assessments in a multi-product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced. Assists with the preparation and maintenance of User Requirements Specifications. Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations. Conducting risk assessments and supporting equipment/utilities qualification activities. Hands-on experience with troubleshooting and resolving process equipment-related issues during production. Experience managing equipment, Preventive Maintenance, Calibration, and reliability programs independently with minimum supervision. Experience with OSD equipment but not limited to Wet Granulation systems, Bin Blenders, Encapsulation, Tablet Presses, Tablet Coaters, Roller Compactors, etc. is a must. Experience in packaging equipment like bottle packaging, blister packaging, and powder packaging. Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs. Experience in writing Change Controls, Investigation reports, Work Orders, CAPA, Standard Operating Procedures (SOP), and risk assessments. Analyzing process data and driving continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality. Providing technical support and training to production staff on new processes, equipment, and safety protocols. Identifies and proposes process improvement ideas and collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution. Performs other related duties as assigned. 3 - 5 years of experience in a Process or Equipment engineering role, preferably in the pharmaceutical drug products manufacturing industry. Ability to read and understand engineering drawings such as P&IDs, equipment/facility layout drawings, electrical/pneumatic drawings, and functional specifications. Thorough understanding of cGMP and FDA requirements Strong communication and documentation skills Proven project management skills Experience with equipment qualification following ISPE and ASTM guidelines. Proficient with Microsoft Office Suite, Maximo, Calibration program software, MES, etc. Preferred Qualifications: Prior experience as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing processes and packaging equipment. Familiarity with Sterile F/F equipment qualification is a plus. Familiarity with the IOQ/PQ process/packaging equipment for the pharmaceutical industry. Familiarity with Maximo or equivalent Regulatory Asset Manager software. Experience / Education: Bachelor's degree in engineering (Mechanical, Electrical, Industrial) or a related field. 3-5 years of maintenance experience in a pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing environment. Knowledge / Skills / Abilities: Technical: Strong understanding of engineering principles, process design and optimization, quality control, pharmaceutical manufacturing technologies, equipment, and relevant software. Knowledge of cGMP guidelines and regulatory compliance is essential. Analytical & Problem-Solving: Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions. Soft Skills: Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills. Industry Specific: Familiarity with FDA regulations, cGMP guidelines, Lean Manufacturing, and risk assessment techniques (HAZOP, FMEA). An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/03/2025
Full time
This role will design, develop, optimize, and support GMP drug product manufacturing and packaging process, including equipment, facilities, and control systems at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed. Implementing and maintaining manufacturing process automation and control systems. Participate as a member of cross functional teams in completion of system impact evaluations and system risk assessments in a multi-product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced. Assists with the preparation and maintenance of User Requirements Specifications. Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations. Conducting risk assessments and supporting equipment/utilities qualification activities. Hands-on experience with troubleshooting and resolving process equipment-related issues during production. Experience managing equipment, Preventive Maintenance, Calibration, and reliability programs independently with minimum supervision. Experience with OSD equipment but not limited to Wet Granulation systems, Bin Blenders, Encapsulation, Tablet Presses, Tablet Coaters, Roller Compactors, etc. is a must. Experience in packaging equipment like bottle packaging, blister packaging, and powder packaging. Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs. Experience in writing Change Controls, Investigation reports, Work Orders, CAPA, Standard Operating Procedures (SOP), and risk assessments. Analyzing process data and driving continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality. Providing technical support and training to production staff on new processes, equipment, and safety protocols. Identifies and proposes process improvement ideas and collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution. Performs other related duties as assigned. 3 - 5 years of experience in a Process or Equipment engineering role, preferably in the pharmaceutical drug products manufacturing industry. Ability to read and understand engineering drawings such as P&IDs, equipment/facility layout drawings, electrical/pneumatic drawings, and functional specifications. Thorough understanding of cGMP and FDA requirements Strong communication and documentation skills Proven project management skills Experience with equipment qualification following ISPE and ASTM guidelines. Proficient with Microsoft Office Suite, Maximo, Calibration program software, MES, etc. Preferred Qualifications: Prior experience as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing processes and packaging equipment. Familiarity with Sterile F/F equipment qualification is a plus. Familiarity with the IOQ/PQ process/packaging equipment for the pharmaceutical industry. Familiarity with Maximo or equivalent Regulatory Asset Manager software. Experience / Education: Bachelor's degree in engineering (Mechanical, Electrical, Industrial) or a related field. 3-5 years of maintenance experience in a pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing environment. Knowledge / Skills / Abilities: Technical: Strong understanding of engineering principles, process design and optimization, quality control, pharmaceutical manufacturing technologies, equipment, and relevant software. Knowledge of cGMP guidelines and regulatory compliance is essential. Analytical & Problem-Solving: Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions. Soft Skills: Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills. Industry Specific: Familiarity with FDA regulations, cGMP guidelines, Lean Manufacturing, and risk assessment techniques (HAZOP, FMEA). An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
We are seeking a skilled and experienced Utilities Superintendent to oversee the operation, maintenance, and reliability of all utilities, facilities, and grounds for our pharmaceutical manufacturing facility in Middletown DE. This role is responsible for ensuring all utilities equipment, automation & controls, and facilities are operated efficiently, safely, and maintained in compliance with Good Engineering Practices. The ideal candidate will lead a team of multi-skilled operators and maintenance technicians, manage vendor service contracts, and implement preventive/predictive maintenance programs, while working closely with cross-functional teams to support production goals and continuous improvement initiatives. Arrange and support routine maintenance activities on all utilities equipment including but not limited to Hurst Boilers, York Chillers, Marley Cooling Towers, Kaeser Air Compressors, BWT PW System, Durr RTO, and Caterpillar Emergency Diesel Generators, Develop and implement the Preventive Maintenance programs on all utilities equipment and systems Develop and implement a comprehensive Predictive Maintenance program including electrical system thermography, rotating equipment vibration analysis, and oil sampling Ensure safe and efficient operation of all utilities equipment and systems Ensure all direct reports and contractors work safely and in strict accordance with all WuXi EHS directives, policies and procedures Propose new technology, new materials and new equipment to enhance existing utilities maintenance level Effectively manage on hand quantities of all necessary spare parts to ensure reliable equipment and systems operation Responsible for the development of departmental Standard Operating Procedures (SOP's) and emergency response policies/procedures for utility maintenance operations. Organize ongoing training programs for the Utilities Team Ensure the optimization of the performance and efficiency of all utilities equipment and systems Manage the overall site Energy Efficiency programs including various utility supply contracts for natural gas and electricity with local regulating agencies Act as official liaison to the Town of Middletown for all utility related issues - electricity supply, effluent water treatment, etc. Act as official liaison to the state regulatory agency DNREC and manage all aspects of the Title V air emissions permitting program for boiler Nox emissions and operation of Regenerative Thermal Oxidizer RTO Manage all facilities and grounds contracts including but not limited to lawn care & snow removal, janitorial services, garbage disposal and recycling, uniforms, gas cylinders, universal waste disposal, etc. Implement Root Cause Analysis (RCA) or other similar reliability based protocols on all equipment failures Regulatory Compliance & Documentation Maintain accurate records of all maintenance activities, work orders, SOPs, calibration, and validation reports. Ensure all equipment and systems are properly qualified and validated per regulatory standards. Participate in audits and regulatory inspections, providing necessary maintenance documentation and reports Responsible for state of Delaware licensing of high-pressure boiler equipment operators Strong working knowledge of all EHS protocols including Safe Work Permitting, Lock Out/Tag Out, Confined Space Entry, Energized Equipment Work, Elevated Work, Hot Work, Lifting Equipment Usage, Underground Excavation Working knowledge of electrical systems from 27.3 KV down to 480 Volts Team Leadership & Training Lead and manage a team of multi-skilled maintenance technicians and equipment operators Provide technical support and guidance to operations and maintenance personnel including training on utilities equipment operation and maintenance. Foster a culture of safety, quality, and continuous improvement within the Utilities department Collaborate with cross-functional teams, including Production, Quality Assurance, Engineering, and Safety teams. Continuous Improvement & Cost Management Identify and implement efficiency improvements to optimize operation & maintenance operations and to reduce costs. Manage the Utilities Equipment Operating Budget and the associated Maintenance support budget, spare parts inventory, and vendor contracts to ensure cost-effective maintenance solutions. Recommend and implement energy-saving and sustainability initiatives to improve overall facility performance Manage the ongoing annual Capital Improvement budget for all Utilities equipment and systems Bachelor's of Science degree in Engineering (Mechanical, Electrical, Chemical, Industrial, etc.) or a related field required 5+ years of specific Utilities equipment operation and maintenance experience in a Life Sciences/Pharmaceuticals/Biotechnology or FDA-regulated environment required Strong knowledge of GMP, FDA, OSHA, and industry best practices in Utilities Equipment and systems operation and maintenance Hands-on past experience with cleanrooms, HVAC systems, water purification, compressed air, electrical systems, pressure/temperature/flow instrumentation, instrumentation testing & calibration, and automation systems a plus Knowledge of PLC's, HMI's, SCADA, Building Management Systems (BMS), and Environmental Management Systems (EMS) a plus. Experience with Computerized Maintenance Management Systems (CMMS) - past experience with SAP R/4 HANA EAM module is a definite plus Excellent problem-solving, leadership, and project management skills Ability to work in a fast-paced, highly regulated environment. Certification in Lean Manufacturing, Six Sigma, or Reliability-Centered Maintenance (RCM) is a plus Strong hands-on leadership style Proficient in oral & written communication skills Demonstrated ability to read, write and speak English Past experience with AutoCAD or other drawing management system is a plus Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint) 10% travel is possible; both domestic and international Physical Requirements: Must be able to work in an office environment with minimal noise conditions Must be able to wear appropriate PPE Must be able to work in a plant environment with variable noise levels Ability to stand/sit/walk for long periods of time Ability to lift 10 lbs. routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs. routinely / often / occasionally Clarity of vision Ability to identify and distinguish colors Must be able to perform activities with repetitive motions Ability to climb ladders / stairs / scaffolding Ability to work in variable temperatures (hot, cold, etc.) Ability to work both inside and outside in varying working conditions
10/03/2025
Full time
We are seeking a skilled and experienced Utilities Superintendent to oversee the operation, maintenance, and reliability of all utilities, facilities, and grounds for our pharmaceutical manufacturing facility in Middletown DE. This role is responsible for ensuring all utilities equipment, automation & controls, and facilities are operated efficiently, safely, and maintained in compliance with Good Engineering Practices. The ideal candidate will lead a team of multi-skilled operators and maintenance technicians, manage vendor service contracts, and implement preventive/predictive maintenance programs, while working closely with cross-functional teams to support production goals and continuous improvement initiatives. Arrange and support routine maintenance activities on all utilities equipment including but not limited to Hurst Boilers, York Chillers, Marley Cooling Towers, Kaeser Air Compressors, BWT PW System, Durr RTO, and Caterpillar Emergency Diesel Generators, Develop and implement the Preventive Maintenance programs on all utilities equipment and systems Develop and implement a comprehensive Predictive Maintenance program including electrical system thermography, rotating equipment vibration analysis, and oil sampling Ensure safe and efficient operation of all utilities equipment and systems Ensure all direct reports and contractors work safely and in strict accordance with all WuXi EHS directives, policies and procedures Propose new technology, new materials and new equipment to enhance existing utilities maintenance level Effectively manage on hand quantities of all necessary spare parts to ensure reliable equipment and systems operation Responsible for the development of departmental Standard Operating Procedures (SOP's) and emergency response policies/procedures for utility maintenance operations. Organize ongoing training programs for the Utilities Team Ensure the optimization of the performance and efficiency of all utilities equipment and systems Manage the overall site Energy Efficiency programs including various utility supply contracts for natural gas and electricity with local regulating agencies Act as official liaison to the Town of Middletown for all utility related issues - electricity supply, effluent water treatment, etc. Act as official liaison to the state regulatory agency DNREC and manage all aspects of the Title V air emissions permitting program for boiler Nox emissions and operation of Regenerative Thermal Oxidizer RTO Manage all facilities and grounds contracts including but not limited to lawn care & snow removal, janitorial services, garbage disposal and recycling, uniforms, gas cylinders, universal waste disposal, etc. Implement Root Cause Analysis (RCA) or other similar reliability based protocols on all equipment failures Regulatory Compliance & Documentation Maintain accurate records of all maintenance activities, work orders, SOPs, calibration, and validation reports. Ensure all equipment and systems are properly qualified and validated per regulatory standards. Participate in audits and regulatory inspections, providing necessary maintenance documentation and reports Responsible for state of Delaware licensing of high-pressure boiler equipment operators Strong working knowledge of all EHS protocols including Safe Work Permitting, Lock Out/Tag Out, Confined Space Entry, Energized Equipment Work, Elevated Work, Hot Work, Lifting Equipment Usage, Underground Excavation Working knowledge of electrical systems from 27.3 KV down to 480 Volts Team Leadership & Training Lead and manage a team of multi-skilled maintenance technicians and equipment operators Provide technical support and guidance to operations and maintenance personnel including training on utilities equipment operation and maintenance. Foster a culture of safety, quality, and continuous improvement within the Utilities department Collaborate with cross-functional teams, including Production, Quality Assurance, Engineering, and Safety teams. Continuous Improvement & Cost Management Identify and implement efficiency improvements to optimize operation & maintenance operations and to reduce costs. Manage the Utilities Equipment Operating Budget and the associated Maintenance support budget, spare parts inventory, and vendor contracts to ensure cost-effective maintenance solutions. Recommend and implement energy-saving and sustainability initiatives to improve overall facility performance Manage the ongoing annual Capital Improvement budget for all Utilities equipment and systems Bachelor's of Science degree in Engineering (Mechanical, Electrical, Chemical, Industrial, etc.) or a related field required 5+ years of specific Utilities equipment operation and maintenance experience in a Life Sciences/Pharmaceuticals/Biotechnology or FDA-regulated environment required Strong knowledge of GMP, FDA, OSHA, and industry best practices in Utilities Equipment and systems operation and maintenance Hands-on past experience with cleanrooms, HVAC systems, water purification, compressed air, electrical systems, pressure/temperature/flow instrumentation, instrumentation testing & calibration, and automation systems a plus Knowledge of PLC's, HMI's, SCADA, Building Management Systems (BMS), and Environmental Management Systems (EMS) a plus. Experience with Computerized Maintenance Management Systems (CMMS) - past experience with SAP R/4 HANA EAM module is a definite plus Excellent problem-solving, leadership, and project management skills Ability to work in a fast-paced, highly regulated environment. Certification in Lean Manufacturing, Six Sigma, or Reliability-Centered Maintenance (RCM) is a plus Strong hands-on leadership style Proficient in oral & written communication skills Demonstrated ability to read, write and speak English Past experience with AutoCAD or other drawing management system is a plus Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint) 10% travel is possible; both domestic and international Physical Requirements: Must be able to work in an office environment with minimal noise conditions Must be able to wear appropriate PPE Must be able to work in a plant environment with variable noise levels Ability to stand/sit/walk for long periods of time Ability to lift 10 lbs. routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs. routinely / often / occasionally Clarity of vision Ability to identify and distinguish colors Must be able to perform activities with repetitive motions Ability to climb ladders / stairs / scaffolding Ability to work in variable temperatures (hot, cold, etc.) Ability to work both inside and outside in varying working conditions
The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical in this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Plan work and supply needs. Communicate and explain work instructions. Train or ensure training of staff on procedures (as the Job Qualified Trainer). Assign workstations, lead, and coordinate team activities. Troubleshoot technical issues and make necessary adjustments (with support services if needed). Operate production lines when permanent operators are absent. Maintain team cohesion and motivation. Propose and implement improvements in work organization. Review production packaging records before Quality Assurance review. Serve as the main contact point during audits in the area. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Promote safe behaviors and practices, verify EHS rules are implemented and followed. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Preferred Qualifications: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Experience / Education A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimum guidance. Languages: English Knowledge / Skills / Abilities: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Natural leadership, able to share expertise, technical knowledge, and experience to develop the team. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting. Proactive in proposing and implementing work organization improvements. Strong problem-solving skills. Able to communicate activity progress and issues encountered. Capable of leading continuous improvement projects with support departments. Strong sense of responsibility. Ability to manage projects. Comfortable giving presentations to groups. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/01/2025
Full time
The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical in this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Plan work and supply needs. Communicate and explain work instructions. Train or ensure training of staff on procedures (as the Job Qualified Trainer). Assign workstations, lead, and coordinate team activities. Troubleshoot technical issues and make necessary adjustments (with support services if needed). Operate production lines when permanent operators are absent. Maintain team cohesion and motivation. Propose and implement improvements in work organization. Review production packaging records before Quality Assurance review. Serve as the main contact point during audits in the area. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Promote safe behaviors and practices, verify EHS rules are implemented and followed. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Preferred Qualifications: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Experience / Education A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimum guidance. Languages: English Knowledge / Skills / Abilities: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Natural leadership, able to share expertise, technical knowledge, and experience to develop the team. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting. Proactive in proposing and implementing work organization improvements. Strong problem-solving skills. Able to communicate activity progress and issues encountered. Capable of leading continuous improvement projects with support departments. Strong sense of responsibility. Ability to manage projects. Comfortable giving presentations to groups. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
The Portfolio Manager plays a pivotal role in managing key accounts, fostering client relationships, and coordinating program workflows to drive the growth and expansion of our comprehensive drug discovery services. Responsible for the strategic oversight and management of the assigned portfolio of projects and programs. This role involves selecting, prioritizing and optimizing initiatives to align with the business goals, maximize return on investment (ROI) and manage risks. The Portfolio Manager collaborates with senior leadership, program managers, and project teams to ensure efficient resource allocation and delivery of strategic outcomes. They play a critical role in balancing competing priorities, monitoring portfolio performance and driving organizational success. Please note this job requires bilingual skills in English and Mandarin. Essential Job Functions : Key Account Management Serve as the primary point of contact for project management and client relationship development in cooperation with Business Development and Technical teams. Develop and transition potential accounts into key accounts, driving service penetration across in-vitro and in-vivo services. Maintain strong relationships with key stakeholders to ensure client satisfaction and retention. Integrated Drug Discovery Program Management Coordinate program workflows to ensure efficient execution and expansion. Deliver customized proposals to clients to increase the win rate for new projects. Manage and integrate resources to oversee the program effectively, expanding services to adapt to client needs and market trends. Solution Provider for Other Integrated Collaboration Develop and implement integrated solutions that facilitate collaboration across various segments and enhance project-related initiatives. Provide customized services aimed at improving project outcomes and streamlining workflows across different teams and departments. Utilize expertise in multiple fields to foster effective integrated cooperation and ensure the successful execution of projects. New Inquiry Allocation and Coordination Serve as a member of the Request Center to effectively coordinate and route business inquiries to the appropriate technical team(s), based on their expertise, experience, and other internal guidelines. Portfolio Governance Establish and maintain portfolio management process, including criteria for project selection, prioritization and termination. Performance Monitoring Track portfolio performance using key metrics and report to senior leadership. Stakeholder Collaboration Work with stakeholders and project teams to ensure clear communication, alignment and conflict resolution. Continuous Improvement Identify opportunities to improve portfolio management process and implement best practices. Other duties as assigned. Qualifications & Experience : Education: A minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience. Experience: Proven experience in drug discovery projects, client relationship management, and cross-departmental coordination. Project management experience within the pharmaceutical or biotechnology industry is highly desirable. Industry Knowledge: Strong understanding of drug discovery and development processes, particularly in preclinical research and CRO environments. Knowledge / Skills / Abilities : Proficient in drug discovery processes, including in-vitro and in-vivo methodologies Proven ability to deliver customized solutions and manage complex projects Ability to work independently and collaboratively in a fast-paced environment Self-Motivation & Organization: Highly self-motivated, well-organized, and detail-oriented, with a strong commitment to follow-through. Communication & Presentation: Outstanding verbal and written communication skills, along with strong presentation, negotiation, and problem-solving abilities ; able to maintain a positive and professional demeanor in all interactions. Fluent in Chinese is a requirement. Teamwork & Collaboration: Ability to work effectively in team settings and build strong collaborative relationships with management, R&D leaders, and the BD team from diverse backgrounds to deliver optimal client solutions. Prioritization & Independence: Proven ability to prioritize tasks, multitask efficiently, and work effectively with minimal supervision. Problem-Solving & Adaptability: Capable of handling challenging situations and developing solutions that drive business success; Ability to thrive in a fast-paced environment while managing multiple projects and priorities simultaneously. Technical Proficiency: Proficiency in Microsoft Office Suite; familiarity with CRM/Salesforce tools is a plus . Travel Flexibility: Willingness and ability to travel (if this is applicable what travel percentage). Physical Requirements : Must be able to work in an onsite office environment. Ability to stand /sit/walk for long periods of time. Must be able to perform some activities with repetitive motion, such as keyboarding. Must be able to travel for long distances in various methods of transportation (e.g. car, airplane, shuttle bus, train, etc.) Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop. Must be able to work in environment with variable noise levels. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/01/2025
Full time
The Portfolio Manager plays a pivotal role in managing key accounts, fostering client relationships, and coordinating program workflows to drive the growth and expansion of our comprehensive drug discovery services. Responsible for the strategic oversight and management of the assigned portfolio of projects and programs. This role involves selecting, prioritizing and optimizing initiatives to align with the business goals, maximize return on investment (ROI) and manage risks. The Portfolio Manager collaborates with senior leadership, program managers, and project teams to ensure efficient resource allocation and delivery of strategic outcomes. They play a critical role in balancing competing priorities, monitoring portfolio performance and driving organizational success. Please note this job requires bilingual skills in English and Mandarin. Essential Job Functions : Key Account Management Serve as the primary point of contact for project management and client relationship development in cooperation with Business Development and Technical teams. Develop and transition potential accounts into key accounts, driving service penetration across in-vitro and in-vivo services. Maintain strong relationships with key stakeholders to ensure client satisfaction and retention. Integrated Drug Discovery Program Management Coordinate program workflows to ensure efficient execution and expansion. Deliver customized proposals to clients to increase the win rate for new projects. Manage and integrate resources to oversee the program effectively, expanding services to adapt to client needs and market trends. Solution Provider for Other Integrated Collaboration Develop and implement integrated solutions that facilitate collaboration across various segments and enhance project-related initiatives. Provide customized services aimed at improving project outcomes and streamlining workflows across different teams and departments. Utilize expertise in multiple fields to foster effective integrated cooperation and ensure the successful execution of projects. New Inquiry Allocation and Coordination Serve as a member of the Request Center to effectively coordinate and route business inquiries to the appropriate technical team(s), based on their expertise, experience, and other internal guidelines. Portfolio Governance Establish and maintain portfolio management process, including criteria for project selection, prioritization and termination. Performance Monitoring Track portfolio performance using key metrics and report to senior leadership. Stakeholder Collaboration Work with stakeholders and project teams to ensure clear communication, alignment and conflict resolution. Continuous Improvement Identify opportunities to improve portfolio management process and implement best practices. Other duties as assigned. Qualifications & Experience : Education: A minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience. Experience: Proven experience in drug discovery projects, client relationship management, and cross-departmental coordination. Project management experience within the pharmaceutical or biotechnology industry is highly desirable. Industry Knowledge: Strong understanding of drug discovery and development processes, particularly in preclinical research and CRO environments. Knowledge / Skills / Abilities : Proficient in drug discovery processes, including in-vitro and in-vivo methodologies Proven ability to deliver customized solutions and manage complex projects Ability to work independently and collaboratively in a fast-paced environment Self-Motivation & Organization: Highly self-motivated, well-organized, and detail-oriented, with a strong commitment to follow-through. Communication & Presentation: Outstanding verbal and written communication skills, along with strong presentation, negotiation, and problem-solving abilities ; able to maintain a positive and professional demeanor in all interactions. Fluent in Chinese is a requirement. Teamwork & Collaboration: Ability to work effectively in team settings and build strong collaborative relationships with management, R&D leaders, and the BD team from diverse backgrounds to deliver optimal client solutions. Prioritization & Independence: Proven ability to prioritize tasks, multitask efficiently, and work effectively with minimal supervision. Problem-Solving & Adaptability: Capable of handling challenging situations and developing solutions that drive business success; Ability to thrive in a fast-paced environment while managing multiple projects and priorities simultaneously. Technical Proficiency: Proficiency in Microsoft Office Suite; familiarity with CRM/Salesforce tools is a plus . Travel Flexibility: Willingness and ability to travel (if this is applicable what travel percentage). Physical Requirements : Must be able to work in an onsite office environment. Ability to stand /sit/walk for long periods of time. Must be able to perform some activities with repetitive motion, such as keyboarding. Must be able to travel for long distances in various methods of transportation (e.g. car, airplane, shuttle bus, train, etc.) Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop. Must be able to work in environment with variable noise levels. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
We are a fast-growing research and services division in WuXi AppTec and are working on developing cutting-edge multidisciplinary drug discovery platforms combining the latest technologies in biology, chemistry, biophysics, engineering, and informatics. We are seeking a highly motivated and collaborative biophysicist to play an integral role in expanding the capabilities at our site in Natick MA. This position is critical to the successful development, implementation and business operations of biophysics platforms and services for the business unit. Designs and executes novel SPR, TSA, and other biophysics studies, including protein-small molecule interactions, protein-protein interactions, and fragment screening. Analyzes and interprets biophysical data. Works closely with clients to establish assays. Prepares scientific reports and presents scientific data. Develops workflow and processes. Mentors junior scientists in the lab. Works broadly and flexibly with the biophysics business group across different geographic regions. Contribute to troubleshooting, planning, and biophysics strategy as a key member of the biophysics group. Develops and performs orthogonal target engagement, or additional binding assays in line with project requirements. Experience / Education Bachelor's with 14+ years' experience; Master's with 10+ years' experience, or PhD with 6+ years' experience. Master or PhD degree is preferred in Biochemistry or Biophysics. Industry experience in Pharma/Biotech and/or drug R&D process is preferred. Proven hands-on experience with developing and troubleshooting biophysical assays (SPR, MST, DSF/TSA, GCI, ITC and/or MS). Deep understanding of binding kinetics and rigorous data analysis Demonstrated understanding of complex scientific procedures and technical proficiency with in vitro assays. Knowledge / Skills / Abilities: Ability to demonstrate scientific creativity, critical thinking and fast learning capabilities. Outstanding written and oral communication skills. Interpersonal skills to seamlessly fit within a teamwork driven environment. Ability to effectively communicate with internal team colleagues and external clients to promote world class service. Must be able to read, write and understand English. Physical Requirements: Must be able to work in an office environment with minimal noise conditions. Must be able to work in a lab setting with exposure to biohazards, chemicals Must be able to wear appropriate PPE Must be able to work in an environment with variable noise levels Ability to stand/sit/walk for long periods Ability to lift 10 lbs. routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs. routinely Clarity of Vision An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/01/2025
Full time
We are a fast-growing research and services division in WuXi AppTec and are working on developing cutting-edge multidisciplinary drug discovery platforms combining the latest technologies in biology, chemistry, biophysics, engineering, and informatics. We are seeking a highly motivated and collaborative biophysicist to play an integral role in expanding the capabilities at our site in Natick MA. This position is critical to the successful development, implementation and business operations of biophysics platforms and services for the business unit. Designs and executes novel SPR, TSA, and other biophysics studies, including protein-small molecule interactions, protein-protein interactions, and fragment screening. Analyzes and interprets biophysical data. Works closely with clients to establish assays. Prepares scientific reports and presents scientific data. Develops workflow and processes. Mentors junior scientists in the lab. Works broadly and flexibly with the biophysics business group across different geographic regions. Contribute to troubleshooting, planning, and biophysics strategy as a key member of the biophysics group. Develops and performs orthogonal target engagement, or additional binding assays in line with project requirements. Experience / Education Bachelor's with 14+ years' experience; Master's with 10+ years' experience, or PhD with 6+ years' experience. Master or PhD degree is preferred in Biochemistry or Biophysics. Industry experience in Pharma/Biotech and/or drug R&D process is preferred. Proven hands-on experience with developing and troubleshooting biophysical assays (SPR, MST, DSF/TSA, GCI, ITC and/or MS). Deep understanding of binding kinetics and rigorous data analysis Demonstrated understanding of complex scientific procedures and technical proficiency with in vitro assays. Knowledge / Skills / Abilities: Ability to demonstrate scientific creativity, critical thinking and fast learning capabilities. Outstanding written and oral communication skills. Interpersonal skills to seamlessly fit within a teamwork driven environment. Ability to effectively communicate with internal team colleagues and external clients to promote world class service. Must be able to read, write and understand English. Physical Requirements: Must be able to work in an office environment with minimal noise conditions. Must be able to work in a lab setting with exposure to biohazards, chemicals Must be able to wear appropriate PPE Must be able to work in an environment with variable noise levels Ability to stand/sit/walk for long periods Ability to lift 10 lbs. routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs. routinely Clarity of Vision An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
The Portfolio Manager plays a pivotal role in managing key accounts, fostering client relationships, and coordinating program workflows to drive the growth and expansion of our comprehensive drug discovery services. Responsible for the strategic oversight and management of the assigned portfolio of projects and programs. This role involves selecting, prioritizing and optimizing initiatives to align with the business goals, maximize return on investment (ROI) and manage risks. The Portfolio Manager collaborates with senior leadership, program managers, and project teams to ensure efficient resource allocation and delivery of strategic outcomes. They play a critical role in balancing competing priorities, monitoring portfolio performance and driving organizational success. Please note this job requires bilingual skills in English and Mandarin. Essential Job Functions : Key Account Management Serve as the primary point of contact for project management and client relationship development in cooperation with Business Development and Technical teams. Develop and transition potential accounts into key accounts, driving service penetration across in-vitro and in-vivo services. Maintain strong relationships with key stakeholders to ensure client satisfaction and retention. Integrated Drug Discovery Program Management Coordinate program workflows to ensure efficient execution and expansion. Deliver customized proposals to clients to increase the win rate for new projects. Manage and integrate resources to oversee the program effectively, expanding services to adapt to client needs and market trends. Solution Provider for Other Integrated Collaboration Develop and implement integrated solutions that facilitate collaboration across various segments and enhance project-related initiatives. Provide customized services aimed at improving project outcomes and streamlining workflows across different teams and departments. Utilize expertise in multiple fields to foster effective integrated cooperation and ensure the successful execution of projects. New Inquiry Allocation and Coordination Serve as a member of the Request Center to effectively coordinate and route business inquiries to the appropriate technical team(s), based on their expertise, experience, and other internal guidelines. Portfolio Governance Establish and maintain portfolio management process, including criteria for project selection, prioritization and termination. Performance Monitoring Track portfolio performance using key metrics and report to senior leadership. Stakeholder Collaboration Work with stakeholders and project teams to ensure clear communication, alignment and conflict resolution. Continuous Improvement Identify opportunities to improve portfolio management process and implement best practices. Other duties as assigned. Qualifications & Experience : Education: A minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience. Experience: Proven experience in drug discovery projects, client relationship management, and cross-departmental coordination. Project management experience within the pharmaceutical or biotechnology industry is highly desirable. Industry Knowledge: Strong understanding of drug discovery and development processes, particularly in preclinical research and CRO environments. Knowledge / Skills / Abilities : Proficient in drug discovery processes, including in-vitro and in-vivo methodologies Proven ability to deliver customized solutions and manage complex projects Ability to work independently and collaboratively in a fast-paced environment Self-Motivation & Organization: Highly self-motivated, well-organized, and detail-oriented, with a strong commitment to follow-through. Communication & Presentation: Outstanding verbal and written communication skills, along with strong presentation, negotiation, and problem-solving abilities ; able to maintain a positive and professional demeanor in all interactions. Fluent in Chinese is a requirement. Teamwork & Collaboration: Ability to work effectively in team settings and build strong collaborative relationships with management, R&D leaders, and the BD team from diverse backgrounds to deliver optimal client solutions. Prioritization & Independence: Proven ability to prioritize tasks, multitask efficiently, and work effectively with minimal supervision. Problem-Solving & Adaptability: Capable of handling challenging situations and developing solutions that drive business success; Ability to thrive in a fast-paced environment while managing multiple projects and priorities simultaneously. Technical Proficiency: Proficiency in Microsoft Office Suite; familiarity with CRM/Salesforce tools is a plus . Travel Flexibility: Willingness and ability to travel (if this is applicable what travel percentage). Physical Requirements : Must be able to work in an onsite office environment. Ability to stand /sit/walk for long periods of time. Must be able to perform some activities with repetitive motion, such as keyboarding. Must be able to travel for long distances in various methods of transportation (e.g. car, airplane, shuttle bus, train, etc.) Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop. Must be able to work in environment with variable noise levels. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/01/2025
Full time
The Portfolio Manager plays a pivotal role in managing key accounts, fostering client relationships, and coordinating program workflows to drive the growth and expansion of our comprehensive drug discovery services. Responsible for the strategic oversight and management of the assigned portfolio of projects and programs. This role involves selecting, prioritizing and optimizing initiatives to align with the business goals, maximize return on investment (ROI) and manage risks. The Portfolio Manager collaborates with senior leadership, program managers, and project teams to ensure efficient resource allocation and delivery of strategic outcomes. They play a critical role in balancing competing priorities, monitoring portfolio performance and driving organizational success. Please note this job requires bilingual skills in English and Mandarin. Essential Job Functions : Key Account Management Serve as the primary point of contact for project management and client relationship development in cooperation with Business Development and Technical teams. Develop and transition potential accounts into key accounts, driving service penetration across in-vitro and in-vivo services. Maintain strong relationships with key stakeholders to ensure client satisfaction and retention. Integrated Drug Discovery Program Management Coordinate program workflows to ensure efficient execution and expansion. Deliver customized proposals to clients to increase the win rate for new projects. Manage and integrate resources to oversee the program effectively, expanding services to adapt to client needs and market trends. Solution Provider for Other Integrated Collaboration Develop and implement integrated solutions that facilitate collaboration across various segments and enhance project-related initiatives. Provide customized services aimed at improving project outcomes and streamlining workflows across different teams and departments. Utilize expertise in multiple fields to foster effective integrated cooperation and ensure the successful execution of projects. New Inquiry Allocation and Coordination Serve as a member of the Request Center to effectively coordinate and route business inquiries to the appropriate technical team(s), based on their expertise, experience, and other internal guidelines. Portfolio Governance Establish and maintain portfolio management process, including criteria for project selection, prioritization and termination. Performance Monitoring Track portfolio performance using key metrics and report to senior leadership. Stakeholder Collaboration Work with stakeholders and project teams to ensure clear communication, alignment and conflict resolution. Continuous Improvement Identify opportunities to improve portfolio management process and implement best practices. Other duties as assigned. Qualifications & Experience : Education: A minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience. Experience: Proven experience in drug discovery projects, client relationship management, and cross-departmental coordination. Project management experience within the pharmaceutical or biotechnology industry is highly desirable. Industry Knowledge: Strong understanding of drug discovery and development processes, particularly in preclinical research and CRO environments. Knowledge / Skills / Abilities : Proficient in drug discovery processes, including in-vitro and in-vivo methodologies Proven ability to deliver customized solutions and manage complex projects Ability to work independently and collaboratively in a fast-paced environment Self-Motivation & Organization: Highly self-motivated, well-organized, and detail-oriented, with a strong commitment to follow-through. Communication & Presentation: Outstanding verbal and written communication skills, along with strong presentation, negotiation, and problem-solving abilities ; able to maintain a positive and professional demeanor in all interactions. Fluent in Chinese is a requirement. Teamwork & Collaboration: Ability to work effectively in team settings and build strong collaborative relationships with management, R&D leaders, and the BD team from diverse backgrounds to deliver optimal client solutions. Prioritization & Independence: Proven ability to prioritize tasks, multitask efficiently, and work effectively with minimal supervision. Problem-Solving & Adaptability: Capable of handling challenging situations and developing solutions that drive business success; Ability to thrive in a fast-paced environment while managing multiple projects and priorities simultaneously. Technical Proficiency: Proficiency in Microsoft Office Suite; familiarity with CRM/Salesforce tools is a plus . Travel Flexibility: Willingness and ability to travel (if this is applicable what travel percentage). Physical Requirements : Must be able to work in an onsite office environment. Ability to stand /sit/walk for long periods of time. Must be able to perform some activities with repetitive motion, such as keyboarding. Must be able to travel for long distances in various methods of transportation (e.g. car, airplane, shuttle bus, train, etc.) Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop. Must be able to work in environment with variable noise levels. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
We are a fast-growing research and services division in WuXi AppTec and are working on developing cutting-edge multidisciplinary drug discovery platforms combining the latest technologies in biology, chemistry, biophysics, engineering, and informatics. We are seeking a highly motivated and collaborative biophysicist to play an integral role in expanding the capabilities at our site in Natick MA. This position is critical to the successful development, implementation and business operations of biophysics platforms and services for the business unit. Designs and executes novel SPR, TSA, and other biophysics studies, including protein-small molecule interactions, protein-protein interactions, and fragment screening. Analyzes and interprets biophysical data. Works closely with clients to establish assays. Prepares scientific reports and presents scientific data. Develops workflow and processes. Mentors junior scientists in the lab. Works broadly and flexibly with the biophysics business group across different geographic regions. Contribute to troubleshooting, planning, and biophysics strategy as a key member of the biophysics group. Develops and performs orthogonal target engagement, or additional binding assays in line with project requirements. Experience / Education Bachelor's with 14+ years' experience; Master's with 10+ years' experience, or PhD with 6+ years' experience. Master or PhD degree is preferred in Biochemistry or Biophysics. Industry experience in Pharma/Biotech and/or drug R&D process is preferred. Proven hands-on experience with developing and troubleshooting biophysical assays (SPR, MST, DSF/TSA, GCI, ITC and/or MS). Deep understanding of binding kinetics and rigorous data analysis Demonstrated understanding of complex scientific procedures and technical proficiency with in vitro assays. Knowledge / Skills / Abilities: Ability to demonstrate scientific creativity, critical thinking and fast learning capabilities. Outstanding written and oral communication skills. Interpersonal skills to seamlessly fit within a teamwork driven environment. Ability to effectively communicate with internal team colleagues and external clients to promote world class service. Must be able to read, write and understand English. Physical Requirements: Must be able to work in an office environment with minimal noise conditions. Must be able to work in a lab setting with exposure to biohazards, chemicals Must be able to wear appropriate PPE Must be able to work in an environment with variable noise levels Ability to stand/sit/walk for long periods Ability to lift 10 lbs. routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs. routinely Clarity of Vision An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/01/2025
Full time
We are a fast-growing research and services division in WuXi AppTec and are working on developing cutting-edge multidisciplinary drug discovery platforms combining the latest technologies in biology, chemistry, biophysics, engineering, and informatics. We are seeking a highly motivated and collaborative biophysicist to play an integral role in expanding the capabilities at our site in Natick MA. This position is critical to the successful development, implementation and business operations of biophysics platforms and services for the business unit. Designs and executes novel SPR, TSA, and other biophysics studies, including protein-small molecule interactions, protein-protein interactions, and fragment screening. Analyzes and interprets biophysical data. Works closely with clients to establish assays. Prepares scientific reports and presents scientific data. Develops workflow and processes. Mentors junior scientists in the lab. Works broadly and flexibly with the biophysics business group across different geographic regions. Contribute to troubleshooting, planning, and biophysics strategy as a key member of the biophysics group. Develops and performs orthogonal target engagement, or additional binding assays in line with project requirements. Experience / Education Bachelor's with 14+ years' experience; Master's with 10+ years' experience, or PhD with 6+ years' experience. Master or PhD degree is preferred in Biochemistry or Biophysics. Industry experience in Pharma/Biotech and/or drug R&D process is preferred. Proven hands-on experience with developing and troubleshooting biophysical assays (SPR, MST, DSF/TSA, GCI, ITC and/or MS). Deep understanding of binding kinetics and rigorous data analysis Demonstrated understanding of complex scientific procedures and technical proficiency with in vitro assays. Knowledge / Skills / Abilities: Ability to demonstrate scientific creativity, critical thinking and fast learning capabilities. Outstanding written and oral communication skills. Interpersonal skills to seamlessly fit within a teamwork driven environment. Ability to effectively communicate with internal team colleagues and external clients to promote world class service. Must be able to read, write and understand English. Physical Requirements: Must be able to work in an office environment with minimal noise conditions. Must be able to work in a lab setting with exposure to biohazards, chemicals Must be able to wear appropriate PPE Must be able to work in an environment with variable noise levels Ability to stand/sit/walk for long periods Ability to lift 10 lbs. routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs. routinely Clarity of Vision An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical in this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Plan work and supply needs. Communicate and explain work instructions. Train or ensure training of staff on procedures (as the Job Qualified Trainer). Assign workstations, lead, and coordinate team activities. Troubleshoot technical issues and make necessary adjustments (with support services if needed). Operate production lines when permanent operators are absent. Maintain team cohesion and motivation. Propose and implement improvements in work organization. Review production packaging records before Quality Assurance review. Serve as the main contact point during audits in the area. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Promote safe behaviors and practices, verify EHS rules are implemented and followed. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Preferred Qualifications: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Experience / Education A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimum guidance. Languages: English Knowledge / Skills / Abilities: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Natural leadership, able to share expertise, technical knowledge, and experience to develop the team. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting. Proactive in proposing and implementing work organization improvements. Strong problem-solving skills. Able to communicate activity progress and issues encountered. Capable of leading continuous improvement projects with support departments. Strong sense of responsibility. Ability to manage projects. Comfortable giving presentations to groups. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
10/01/2025
Full time
The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site's quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas. Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical in this dynamic setting, with open communication and a team-first attitude driving success. Serve as the focal point for supporting the Project Team members in relation to operational activities by demonstrating a proactive approach and the ability to anticipate needs. Coordinate and orchestrate site visits for process equipment vendors for the installation and qualification activities. Assists in the execution of process equipment testing and startup activities, along with developing necessary operational procedures. Collaborate with internal and external stakeholders to initiate and manage 3rd party services for GMP areas. Communicate with external partners, contractors, government departments, and other stakeholders on a variety of different documents and agreements as required. Act as a dedicated member of the Project Team, supporting project execution and taking on responsibilities as assigned by the Site Head. After the site is operationalized, the position will lead the Site Support Team to ensure smooth site administrative operations in collaboration with internal and external parties. Operations & Team Management Plan work and supply needs. Communicate and explain work instructions. Train or ensure training of staff on procedures (as the Job Qualified Trainer). Assign workstations, lead, and coordinate team activities. Troubleshoot technical issues and make necessary adjustments (with support services if needed). Operate production lines when permanent operators are absent. Maintain team cohesion and motivation. Propose and implement improvements in work organization. Review production packaging records before Quality Assurance review. Serve as the main contact point during audits in the area. Compliance & Documentation Ensure execution of industrial batch packaging operations in GMP environments while meeting the established schedule. Ensure compliance with hygiene, environmental, and safety (EHS) rules and guidelines. Check, record, and complete pre-established work documents to ensure traceability of performed operations (batch records completed per GMP standards). Draft technical documents necessary for equipment operation (user and cleaning instructions, etc.) and other documentation required for packaging operations. Open deviations in the quality IT system and ensure timely closure. Perform and follow up on CAPA actions in the quality IT system. Equipment & Process Management Manage the company responsible for GMP cleaning of production areas and establish cleaning schedules in collaboration with them, according to production constraints. Participate in the qualification/validation of packaging production equipment. Maintain packaging line indicators and communicate them to the team. Collaborate with EHS to assess risks and perform risk analyses. Promote continuous improvement within the team. Safety & Risk Management Maintain a healthy and safe working environment in controlled areas and ensure compliance with applicable laws and rules. Ensure staff (including temporary and short-term contracts) are properly informed of risks and trained to act accordingly. Promote safe behaviors and practices, verify EHS rules are implemented and followed. Immediately report all incidents and near misses to the EHS department, participate in investigations, and identify preventive measures to avoid recurrence. Preferred Qualifications: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Experience / Education A minimum of a bachelor's or associate degree with over 6 years of experience in manufacturing site operations. Working knowledge of manufacturing and R&D operations. Proven experience in leading and managing a team. Proficiency in handling local codes and regulations while maintaining international standards. Highly self-motivated individual capable of working with minimum guidance. Languages: English Knowledge / Skills / Abilities: Strong knowledge of GMP environment and solid understanding of the pharmaceutical industry, especially in blending, encapsulation, powder compression, and other oral dosage manufacturing processes. Versatile, organized, rigorous, and an effective communicator with excellent interpersonal skills for teamwork. Natural leadership, able to share expertise, technical knowledge, and experience to develop the team. Strong management skills. Proficient in basic IT tools (Word, Excel, PowerPoint) and ERP systems; able to use them for presentations and reporting. Proactive in proposing and implementing work organization improvements. Strong problem-solving skills. Able to communicate activity progress and issues encountered. Capable of leading continuous improvement projects with support departments. Strong sense of responsibility. Ability to manage projects. Comfortable giving presentations to groups. Knowledge of various packaging processes in dry formulation. Willing to share knowledge and train new employees and operators on packaging equipment. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.