Emergent BioSolutions

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Job Summary The Automation Engineer will be responsible for supporting automation and control systems at the Emergent Biosolutions Bayview Manufacturing site. This will include supporting the long-term strategic development goals for the site automation systems, ensuring compliant operation of all validated control systems, as well as supporting day-to-day trouble-shooting and problem-solving activities associated with existing site and equipment-based control systems. This role will also support multiple projects of varying complexity and size which will include outside control system integrators, technicians, IT infrastructure, manufacturing personnel, validation personnel, and quality control/quality assurance. Essential Functions Work independently as well as within multidisciplinary teams to provide routine support of site manufacturing and facility operations, specifically relating to control, automation, and instrumentation systems. Responsible for the site PLC-based Control System, Building Management Systems, and Environmental Monitoring System, including monitoring and maintaining control system hardware, wiring, and instrumentation. Troubleshoot and provide corrective actions for existing manufacturing and facility control systems, automation, and instrumentation. Prepare and/or review engineering standards and approve submittals. Develop, review and/or approve Preventive Maintenance Plans, Standard Operating Procedures, IQ/OQs, commissioning protocols, user requirement specifications, acceptance test plans, Functional Specifications, Design Specifications, and drawings and diagrams. Work with site Quality and Computer System Validation personnel to ensure automation and control system GMP compliance. Implement and complete change controls, CAPAs, and Deviations for automated GMP systems and equipment. May be responsible for leading teams as well as functioning in a supporting role for team efforts. Proactively search for and implement innovative solutions to improve system performance, reliability, and compliance. Support training efforts for new equipment installations The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Minimum Education, Experience, and Skills Bachelor's degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines 5+ years' experience supporting or developing automated systems Experience in pharmaceutical, biopharmaceutical, or consumer healthcare manufacturing Proven programming and maintenance experience with Allen-Bradley/Rockwell PLCs as well as Rockwell Software applications, including FactoryTalk SE/ME, Studio 5000, etc. Knowledge of Building Management/Automation Systems Experience with supporting and maintaining automation and control system infrastructure, including PLCs, remote I/O panels, BMS equipment, wiring and cabling systems, as well as proprietary equipment controllers and control systems Experience with various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, BACnet and/or Profibus Works and communicates well in a multi-discipline team structure Demonstrates skills in requirements gathering, design, configuration, integration, and implementation of process control solutions for the manufacturing industry including batch software, PLC based control systems, HMI packages, building management systems, SCADA systems, and PC networking technology Preferred Experience Advanced training in process controls engineering Member of ISPE, ISA, or IEEE Working experience with data management software, including OSIsoft Pi Historian, SQL databases, Crystal Reports, etc. Familiar with pharmaceutical industry guidelines such as ISPE Baseline Guidelines and GAMP as well as ISO and ISA Standards Knowledge of AutoCAD Working knowledge of SAP Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11 Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Equipment Specialist is responsible for maintenance and operational support of all equipment and areas needed for the manufacture of parenteral pharmaceuticals at the Baltimore Camden fill/finish facility. Additional duties will include parts and tool management, plant equipment support, parts design, as well as management of moderately sized capital projects. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Comply with cGMP regulations, adhere to company policies, and adhere to SOP and Batch Record directions Assist the Validation with the operation and execution of engineering projects. Provide technical expertise for these projects Provide technical support during manufacturing activities Focus to continually improve processes throughout the manufacturing and packaging areas. Coordinates and performs preventive/reactive maintenance on production and facility equipment Maintains detailed maintenance records Coordinates contracted maintenance activities with vendors Assists in qualification of equipment / facilities as needed Compiles, analyzes, draws conclusions and provides written documentation related to the maintenance and lifecycle of production systems Administers project management controls and reports status to senior management Involved in the oversight and coordination of activities that include design, specification creation, procurement, construction management, repair of production and facilities equipment Researches new technologies and procedures to enhance production and performs engineering design evaluations Applies creative and sound troubleshooting techniques to generate timely solutions to problems Assignments are broad in nature, requiring originality and ingenuity, and rely on collaboration, limited experience and judgment to plan and accomplish goals Assists in programming, maintenance and troubleshooting of programmable logic controllers and process/environmental monitoring systems Establish procedures with some supervision The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS Bachelors in Engineering or equivalent Engineering Technician/Specialist experience consisting of Technical (Trade/ Military) Training 3-5 years of experience in industrial/pharmaceutical engineering/maintenance setting or transitioning military Basic knowledge of electronics systems is essential Knowledge of 2D and/or 3D electronic drafting preferred Must possess the ability to identify and resolve problems in a timely manner while gathering and analyzing information skillfully PLC and process control troubleshooting skills preferred Proven track record of applying broad knowledge of engineering principles, practices and procedures to the completion of moderately difficult assignments Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I: JOB SUMMARY The Quality Assurance Manager, Raw Materials provides quality oversight and management for the Bayview Raw Material release functions to ensure patient safety and compliance with FDA and other applicable health authority requirements. In addition, the QA Manager provides input for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities. Finally, the QA Manager fosters a culture of quality and compliance through effective leadership and strict adherence to Emergent's core values. II: ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Lead the QA Raw Material release team to assure good alignment with client expectations and on-time batch delivery according to plan. • Develop, implement, and optimize quality processes to achieve site objectives. Build and define respective roles and responsibilities within the QA Raw Material release team and execute in a manner to gain efficiencies in support of site operations. • Must have a strong working knowledge of cGMPs as they relate to the control/release of raw materials, including the knowledge to support deviation investigation/resolution and generation/implementation of identified CAPAs. • Strong computer skills and understanding of SAP or similar electronic inventory management system. • Serve as a member of the Bayview Quality Operations management team. Quality representative for the Material Review Board to assess deviation impact, investigation need and thoroughness of required investigations. • Maintain the QA Raw Material release program in an inspection ready state by regulatory agencies and clients. • Lead daily operational initiatives. The successful candidate will have a proven track record of operational execution while retaining high quality of the deliverables. • Work effectively with various Site functions to align systems across the site. • Participate in U.S. FDA (CBER) and other regulatory agency inspections to defend quality practices within the Raw Material program. • Participate in interdepartmental and operational excellence initiatives. Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site. Candidate must have track record of working effectively in teams to resolve issues and elevate as appropriate. Ability to prioritize and multitask necessary. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III: MINIMUM EDUCATION, EXPERIENCE, SKILLS • Bachelor's Degree in Biology, Chemistry, Engineering, or related fields • A minimum of five (5) years of cGMP Quality experience (QA/QC/Validation) • A minimum of two (2) years in roles of increasing management or project management responsibility in a biopharmaceutical manufacturing environment • Strong communication skills: oral/written and listening • Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability • Interpersonal skills: team building, consensus building, conflict resolution IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. The SAP Master Data Steward is responsible for ensuring that master data definitions, ownership and quality rules are established and clearly documented and maintained; that master data quality is monitored and quality issues are identified and remediated as needed; master data projects are overseen to help ensure that the risk of adverse impacts to master data are minimized. The Master Data Steward works with a wide variety of stakeholders across lines of business, operations, risk, and SAP to help ensure that the people, processes, and technology required to drive sustainable improvements in our Master Data quality and increase the value of our Master Data as a strategic asset are operating effectively and efficiently. Responsibilities Develop global/enterprise focused data definitions, business rules and standards for Master Data. Lead Master Data projects and coordinate with stakeholders to ensure master data milestone dates are met Develop, monitor and enforce data management policies, procedures, and standards. Participate in change initiatives to ensure that the introduction of undesirable impacts to data definition, maintenance, quality and/or consumption are minimized Ensure data is compliant with defined standards, policies and quality requirements Ensure quality of master data through documentation, metrics, and ongoing maintenance. Assist in resolving data quality problems through the appropriate choice of error detection and correction, process control and improvement, or process design strategies collaborating with subject matter experts (SMEs) Analyze data quality for specific teams and across the organization, reporting on findings Validate data quality, integrity, accuracy and consistency Audit, track and report metrics Lead data initiatives and analysis, building cross-team relationships Work with subject matter experts and process owners to improve data quality The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills Education • BS/BA in Information Management, Computer/Information Science, Supply Chain, Business Administration or 10 years of relevant SAP MM experience to include full life cycle implementation. Experience & Skills 3 - 5 years of SAP Master Data experience especially in the manufacturing environment preferably life sciences 3 - 5 years of experience in Supply Chain Management, production planning, Order to Cash, Quality or related fields. SAP Master Data Experience should include expert level understanding of Material Master, Vendor Master, BOM, Routing, Production, Customer Master, Quality etc. Project management skills Ability to audit data across multiple systems to ensure alignment Excellent communication and interpersonal skills that enable effective working relationships with internal and external stakeholders and managing multiple stakeholders at multiple facilities Strong understanding of data management best practices in areas such as metadata management, data quality management, root cause analysis, process design and master and reference data management Excellent verbal & written communication skills; good presentation skills. Excellent computer skills including advanced skills in Excel, SAP APO, & SAP ECC. Advanced analytical skills Excellent attention to detail and accuracy Ability to work independently with minimal supervision Ability to work collaboratively with business stakeholders across geographically distributed sites. Continuous improvement mindset Self-motivated There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. JOB SUMMARY The Specialist I, QA is responsible for assisting and supporting, Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. This entry-level position is suitable for an employee who has a potential for growth and development in all areas of quality support such as supporting internal/external inspections, supply chain management, investigations and corrective and preventative actions. The incumbent may interact with external CMO clients, senior leadership, direct manager, peers, internal customers and other cross functional peers across Emergent to gain alignment on sound quality decisions. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Support/execute QA on the Floor program • Support/execute Raw Material release • Support/execute Batch Record review of executed/Master Batch Records • Support/execute revision and creation of Standard Operating Procedures in document management system • Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA • Support QA oversite for incoming commercial and clinical projects • Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues. • Support the generation of QA operations metrics • Approve Quality Notifications (Deviations, CAPA's and Change Controls) • Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues • Receive assignments in the form of objectives to help achieve department goals • Support Quality Management systems as assigned (Training, Audits, Document Management, Supplier Quality) • Participate in company sponsored training • Support regulatory and client audits • Provide Quality input/support to investigations, CAPA's and changes • Support site inspection readiness strategy and activities • Support internal audits per audit schedule The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS • BS degree or equivalent years of experience in the field. • Minimum 8 years' experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records • Preferred experience in biologic drug substance manufacture • Experienced in application of GMP principles, Minimum of 1 year in an FDA regulated industry. • Strong computer skills with the Microsoft Office product line. • Moderate understanding of regulations governing document control and records management. • Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations. • Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards • Strong communication skills: oral/written and listening • Ability to work individually and in a team environment • Ability to work under pressure and analyze processes within scheduled timeframes • Strong presentation skills, including written and verbal communication skills • Experience in SAP and Technical Writing IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Reporting to the Senior Director of Product Management and Business Operations, this role will be an integral part of the Project Management Organization (PMO). This role will be responsible for leading business unit operations including comprehensive oversight of training and career development for project managers, representing the Vaccines Business Unit (VaxBU) in cross-BU project management efforts, and working on commercial product management activities. The successful candidate must be able to work independently, multi-task, and communicate effectively with all levels of the organization. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. VaxBU Business Operations Lead activities supporting the overall operations of the VaxBU: Integration of VaxBU R&D, PAD, PMO and commercial operations to maximize synergies and streamline operational efficiencies Creating and driving a PMO training plan, curriculum and tracking system ensuring consistent performance from Project Managers in the VaxBU Managing a ladder of career development for employees in the PMO that provides clear guidance on opportunities for professional development and advancement Assist with 5-year planning and long-range goal planning, integration of new company initiatives, and other business-related operational activities MCM Portfolio Product Management Assist the Senior Director, Product Management and Business Operations, with activities related to Medical Countermeasure Product Management: Puts the customer and corporate mission at the heart of execution Support the leadership of the product core teams for the MCM vaccine products. This includes but is not limited to the organization of team meetings, identification, communication, and measurement of goals, execution of long-range and annual planning process, and management of key issues and life cycle planning activities. Partner with the Sr Director of Product Management and BU leads on the management of the P&L for marketed products including attainment of quarterly and annual revenue commitments; development of pricing; and contracting recommendations for the USG or International Government Purchasers Support the development of product positioning statements, creation/maintenance of the Target Product Profile (TPP) and value proposition, and provides market/customer perspective within development core teams Creates presentations for meetings with US Federal and International MCM customers in support of product development and/or procurement activities Builds strong relationships and collaborates with key cross-functional partners including US Federal Public Health and International Government Procurement field teams, Supply Chain, Manufacturing Ops, Medical, Regulatory, Finance, Legal, Corporate Development, and Commercial Operations, Ensures decisions are made by the right stakeholders, identifies gaps/conflicts, and facilitates their resolution to keep team(s)/work moving forward The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS • BA/BS degree required, advanced scientific degree or MBA a plus • 8 years of experience within Project Management, or equivalent work experience. • The ideal candidate will have in-depth understanding of project management systems and processes, the interdependencies of development activities and projects, and the regulatory requirements for product registration. • Excellent management and communication skills, including expert prioritization, team building and the ability to synthesize project management for corporate leadership. • Exceptional leadership skills and proven ability to interact effectively with all levels of the organization. • Highly developed diplomatic negotiation, interpersonal, and communication skills and the ability to influence without formal authority. • Excellent analytical skills and experience developing and managing strategic business plans. • Proven ability to manage and execute projects on time and within budget • PM certification preferred • Able to implement Earned Value Management techniques and provide earned value metrics in monthly reporting on government contracts a plus • Proficiency in Word, Excel, PowerPoint and Project is required • Able to travel as required to meet with contractors, partners, or project funding entities There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. The SAP Finance Master Data Steward is responsible for ensuring that master data definitions, ownership and quality rules are established and clearly documented and maintained; that vendor banking and customer master data quality is monitored and quality issues are identified and remediated as needed; master data projects are overseen to help ensure that the risk of adverse impacts to master data are minimized. The Finance Master Data Steward works with a wide variety of stakeholders across lines of business, operations, risk, and SAP to help ensure that the people, processes, and technology required to drive sustainable improvements in our Master Data quality and increase the value of our Master Data as a strategic asset are operating effectively and efficiently. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Develop global/enterprise focused data definitions, business rules and standards for Business Services Related Master Data. • Lead Customer and Banking Master Data projects and coordinate with stakeholders to ensure master data milestone dates are met • Develop, monitor and enforce data management policies, procedures, and standards • Participate in change initiatives to ensure that the introduction of undesirable impacts to data definition, maintenance, quality and/or consumption are minimized • Ensure data is compliant with defined standards, policies and quality requirements • Ensure quality of master data through documentation, metrics, and ongoing maintenance • Assist in resolving data quality problems through the appropriate choice of error detection and correction, process control and improvement, or process design strategies collaborating with subject matter experts (SMEs) • Analyze data quality for specific teams and across the organization, reporting on findings • Validate data quality, integrity, accuracy and consistency • Audit, track and report metrics • Lead data initiatives and analysis, building cross-team relationships • Work with subject matter experts and process owners to improve data quality Provide intermittent support to Business Services Team members to include but not limited to transactional data entry, vendor and customer communications as necessary The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Education • BS/BA in Information Management, Finance, Accounting, Computer/Information Science, Supply Chain, Business Administration. Experience & Skills • 3 - 5 years of SAP Master Data experience especially in the manufacturing environment • 3 - 5 years of experience in Supply Chain Management, production planning, Order to Cash, Quality or related fields. SAP Master Data Experience should include expert level understanding of Customer and Vendor Master Data Records • Project management skills • Ability to audit data across multiple systems to ensure alignment • Excellent communication and interpersonal skills that enable effective working relationships with internal and external stakeholders and managing multiple stakeholders at multiple facilities • Strong understanding of data management best practices in areas such as metadata management, data quality management, root cause analysis, process design and master and reference data management • Excellent verbal & written communication skills; good presentation skills. • Excellent computer skills including advanced skills in Excel, SAP APO, & SAP ECC. • Good problem-solving skills • Advanced analytical skills • Excellent attention to detail and accuracy • Ability to work independently with minimal supervision • Ability to work collaboratively with business stakeholders across geographically distributed sites. • Continuous improvement mindset • Ability to travel internationally up to 10% of the time is preferred. • Self-motivated There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Responsible for the overall direction, initiation, planning, coordination, implementation, execution, control and completion of specific projects ensuring consistency with company strategy, commitments and goals. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Lead cross functional project teams. • Facilitate projects and initiatives. • Create/maintain project scope, timelines, budgets, team, project plan and project objectives/goals. • Facilitate strategy discussions with core team members across multi-functional groups. • Facilitate project meetings. • Provide technical leadership to the Lansing site and contract manufacturers in the resolution of technical issues. • Provide project updates/reporting to Project Management, Governance and Steering Team Members. • Provide decision support across multi-functional groups. • Identify and secure resource constraints. • Lead line extensions of current biological for International Sales. • Prepare/champion Process Change Proposals/Requests through appropriate channels. • Lead inter-site best practices (technology transfer, process validation, etc). • Create project plan, risk management plan, communications plan, cost, and timeline baselines. • Track and monitor project progress including financials, schedule, resource constraints, risks, contract status, and other appropriate project performance indicators. • Prepare and conduct presentations to all levels of the organization which may include project technical and budgetary information. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS Bachelor's degree in Biochemical Engineering, Biochemistry, Biology or other science related field. 3 - 5 years project management experience managing projects through all phases of the project lifecycle. PMP Certification Preferred Biopharmaceutical experience; preferably with familiarity/experience with technical transfer. Demonstrated ability to interact effectively with colleagues at all levels of the organization, including senior internal and/or external personnel on matters often requiring coordination between organizations. Strong leadership and facilitation skills. Fluent in project management tools (MS Project). Demonstrated effective written and verbal communication skills. Demonstrated technical and industry-specific expertise in areas of process validation and production of a biopharmaceutical product. Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure. Ability to develop solutions to complex problems which require the use of ingenuity, innovation, and creativity. Capable of working independently and multi-tasking. raining/teaching An established track record of facilitating effective high-quality medical communications Strong organizational skills Strong scientific acumen with the ability to translate and effectively communicate complex scientific data for varying audiences. Strong project management skills with a proven track record to deliver multiple projects in time and excellent quality There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Job Summary The individual will perform various duties as required to support 24/7 Plant and Process operations in a cGMP environment. Essential Functions • Must be able to work 3:00- 11:00, 11:00-7:00 shift including some weekends • Must be able to respond to emergency on call. • Monitor critical plant systems. • Perform daily meter readings. • Assist with trouble shooting of mechanical and electrical systems. • Perform planned and unplanned maintenance. • Work with and manage vendors. • Maintain records of building operations, repairs, parts and equipment. • Assist with the creation of Preventative Maintenance documents and Standard Operating Procedures. • Assist with writing Deviations, CAPAs, Change Controls and SOP Revisions. • Will assist in failure investigations (root cause) and help provide corrective/preventive actions to Deviations and equipment failures • Must comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations and company regulations such as the employee handbook. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills HS Diploma/GED Maryland Second or Third Grade Stationary Engineering License. Universal CFC Refrigerant License preferred. Prior experience working in a clean room preferred. Prior experience with general utility systems, boilers, electrical, HVAC and refrigeration systems. Prior experience with critical utility systems, purified water systems, clean steam, pharmaceutical gasses, classified HVAC systems preferred. Must have the ability to multi-task and coordinate workload by priority. Must be customer service and quality driven. Prior cGMP experience preferred Prior experience in an environment that implemented and maintained advanced maintenance techniques such as preventive and predictive maintenance programs (PMMS, TPM, Predictive Maintenance) preferred. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Manufacturing Sciences and Technology (MS&T) Engineer position is responsible for leading process and technology transfer of one or more processes into a cGMP single use drug substance manufacturing facility. This position conducts, plans and leads tech transfer of processes into manufacturing, as well as collaboration and execution of process validation activities. This role includes preparing and reviewing of tech transfer and validation documentation. This position reports into MS&T Leadership at the Emergent Bayview manufacturing facility. ESSENTIAL FUNCTIONS Conduct, plan and lead tech transfer of one or more processes into manufacturing Perform statistical analyses, and compare manufacturing batches and evaluate process performance Support execution of Continued Process Verification strategy with MS&T team Author and review technology transfer and validation documentation (including run summaries, reports and client presentations) Develop, edit, review and sign cGMP documentation Provide technical support for writing of project proposals, including development of process flow diagrams from process descriptions and development of a bill of materials Support technical writing needs of the MS&T group Select, integrate, evaluate and become subject matter experts of process equipment Support acceptance testing and training on capital equipment Support all MS&T team goals including covering other pipeline projects as necessary to achieve MS&T team goals Develop protocols, execute and report experiments that determine evaluation of key and critical process parameters Travel for person-in-plant (or lab) runs as required for process transfer and troubleshooting Evaluate incoming processes for operability and develop risk assessment plans Responsible for coordination of technical activities on assigned projects Determine equipment requirements and capital expenditure budgets for projects Independently perform review of process control parameters and testing protocols Represents EBS to external customers, at conferences and/or organizations such as ISPE, PDA or ASME The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. MINIMUM EDUCATION, EXPERIENCE, SKILLS Bachelor of Science degree in an engineering discipline with 4+ years of biologics drug substance manufacturing or development experience Strong leadership skills; high level of personal/departmental accountability and responsibility. Biologics manufacturing and/or technology transfer experience in one or more of the following areas: Antibody therapeutics manufacturing Viral or non-viral vaccine manufacturing Microbial protein expression Hands-on biologics expression of vaccines and/or therapeutics in industry Ability to work collaboratively in multi-disciplinary teams Excellent leadership, presentation, computer, and communication skills. Experience using statistics software for process evaluation Proficient with desktop software and basic programming experience Experience with SAP or Equivalent ERP system Experimental design experience Experience with receiving and evaluating technology transfer data, development of bills of materials and evaluation of cGMP manufacturing suitability Experience with writing SOPs, batch records, production protocols, deviation assessments, and technical reports Experience with cGMP and/or EU regulations for biologics manufacturing Experience with identifying, operating and evaluating process equipment Preferred Requirements: Master's degree in an engineering discipline or equivalent with 4+ years of process experience Ability to operate process and analytical equipment and other instruments Familiarity with analytical methodologies for determining protein structure, concentration, and purity Chemical engineering and/or molecular biology background Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. JOB SUMMARY The QC Analyst III, position supports the Quality Control group at Emergent BioSolutions Rockville Campus. The role requires knowledge and understanding of scientific concepts, practices and procedures within the biopharmaceutical field and a cGMP environment. The role is responsible for daily routine testing and laboratory maintenance tasks such as Environmental Monitoring of the GMP area, and sampling and testing of water, compressed air, nitrogen and bioburden testing samples. T Individuals should be able to work independently and participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments. In this role, Individuals will use soft skills, to work on QC schedules and to work with internal customers (EHS, Manufacturing and QA). People leader skills will be cultivated in this role. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Assist the Manager, QC Micro / Analytical with feasibility assessment of client projects Perform microbiological / analytical work per method transfer/ validation programs. Perform environmental monitoring and utility testing of the facility. Performs environmental monitoring during fill operations (as necessary) Write method validation / transfer protocols and reports as necessary. Perform various microbiological / analytical testing procedures per Quality Control batch records and stability protocols. Inform supervisor/manager upon observing OOS, OOL, or generation of deviations. Participate in investigations of OOS results and other related studies.Assist with complex investigations by obtaining root cause and implementing changes. Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues. Write, review, and revise SOP's and Testing Standards as necessary. Train additional employees in methods, transfers and techniques Review, analyze, interpret and report data. Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures. Resource for technical knowledge of current assays Uses analytical and statistical concepts to understand variable sin assays Assess the compliance status of current test methods and equipment Applies analytical knowledge to support change and risk management Review record keeping and documentation of laboratory equipment maintenance. Work with Project Managers and QA to ensure timely review and approval of protocols /reports. Support department compliance and productivity goals. Participate in meetings as required. Track time worked per project. Interview and recommend the employment of technical and professional supporting staff. Identify and implement continuous improvement opportunities to reduce non-value added work or complexity. May require work on weekends and nights, travel, or work with 3rd party vendors. Detailed oriented - Able to complete required tasks and associated documentation with minimal error. Adaptability - Maintain positive attitude in a changing work environment. Communication - Effectively communicates with all levels of manufacturing and support staff. Actively participate in department level meetings. Escalates issues through the proper channels. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Education: BS in Microbiology/Biology or related field Experience: 3-5 years (MS with 3+ years) in the Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes. Track record of achievement and sustained performance in a cGMP/GLP environment. Strong technical and communication skills: oral/written and listening. Personal Competencies: Self - awareness, Integrity, Team Player, Creative and Flexible Skills: Knowledge of MS Word, Excel and PowerPoint. Other Requirements: R equires vaccination against different viruses including Vaccinia virus. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I. SUMMARY The Specialist position will design and prepare all protocols and reports related to novel and diverse validation activities. The candidate will focus on Cleaning, Equipment, Utilities, and Software Validation. The Engineer will network with senior internal and external personnel in their area of expertise and work on problems where analysis of data requires evaluation of identifiable factors and troubleshooting of abnormalities. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Write, execute, and approve validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc. Write summary reports, following good documentation practices. Use Kaye Validator, DataTrace dataloggers, and/or Ellab ValSuite dataloggers to perform mapping studies. Write and revise SOPs as part of process improvements. Analyze statistical data to verify acceptable criteria. Develop testing strategies and rationale for equipment/systems. Provide technical support/troubleshooting for process and equipment issues. Attend production and team meetings, as required. Maintain close contact with manufacturing, facilities, and laboratory departments to assure effective communication on issues related to validation. Apply CGMP guidelines to all aspects of validation. Investigate/resolve deviations associated with validation studies. Assist with commissioning, FATs, and SATs. Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc. Provide technical and/or investigational support in troubleshooting and resolving manufacturing equipment issues. Support the technical transfer team, Project Management, and business development in determining and planning studies required for new products. Perform periodic review of equipment /systems. Critically review complex data to ensure completeness, accuracy and compliance. Qualify change parts for fillers, cappers, vial washers, labeler, cartoner, and serialization machines to support new products. Write and revise SOPs and Master Plans biennially or as part of process improvements. Maintain close contact with Production, Facilities Maintenance, and Laboratory Services to assure effective communication on validation issues. Apply CGMP and CGDP to all areas of work. Support regulatory services with CMC preparation, product reviews and Client and Regulatory audits. Assist in cleaning validation activities and plans associated with projects at the site. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS BS in Science or Engineering with minimum of 5 years of equivalent job experience in pharmaceutical manufacturing. Strong organization and communication skills; high level of personal/departmental accountability and responsibility. Ability to manage multiple priorities and tasks in a dynamic environment. Excellent written and verbal skills. Experience and knowledge of sterile processing (rooms, equipment, HVAC, etc). Ability to exercise judgment to determine appropriate corrective actions. Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions. Ability to use computer programs such as Microsoft Office, EDMS, and SAP. Ability to work in a team environment. Proficient knowledge of CGMP. Coordinate multiple tasks simultaneously. Ability to make sound decisions regarding compliance-related issues with moderate supervision and guidance. Experience and knowledge of HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and aseptic manufacturing is very desirable. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Reporting to the Vice President of Project Management, the Senior Director will be a member of the Project Management Organization's (PMO) Leadership Team and responsible for managing a group of project manager direct reports working on early-stage vaccine pipeline products. The successful candidate is responsible for holding the team accountable for driving the schedule and budget of various projects and integrating all functional plans into a cohesive strategy. The Senior Director is responsible for the professional development of his/her team, ensuring that the team is appropriately trained and capable of delivering on-time. Successful candidates must be capable of working collaboratively with other leaders from various functions (Clinical, Regulatory, Manufacturing Operations, Quality, etc.). The successful candidate must be able to work independently, multi-task, and communicate effectively with all levels of the organization. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. • Lead a team of project management professionals focused on early-stage development of vaccine pipeline products Mentor and train project managers to build the skillsets required for their job Support the professional development and career growth of team members Provide oversight of the team and hold each accountable for delivering on project milestones, tracking to budgets, and operating on-schedule • As part of the PMO leadership team, help build and maintain an infrastructure with long-term capability to support future growth throughout the business unit • Responsible for R&D planning, multi-year resource forecasts, and project risk plans • Responsible for meeting corporate project goals • Understand business unit priorities, and drive project progress accordingly • For projects with major external components, participate in progress/status reporting, including Earned Value Management where required • Identify and resolve gaps/conflicts with function resources The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS • BA/BS degree required, advanced scientific degree or MBA a plus • 10 years of experience within Project Management, or equivalent work experience. • Prior experience in one or more technical disciplines • The ideal candidate will have in-depth understanding of project management systems and processes, the interdependencies of development activities and projects, and the regulatory requirements for product registration. • Experience in vaccine research and development is required, including experience with clinical development and non-clinical development • Excellent management and communication skills, including expert prioritization, team building and the ability to synthesize project management for corporate leadership. • Exceptional leadership skills and proven ability to interact effectively with all levels of the organization. • Highly developed diplomatic negotiation, interpersonal, and communication skills and the ability to influence without formal authority. • Excellent analytical skills and experience developing and managing strategic business plans. • Proven ability to manage and execute projects on time and within budget • PM certification preferred • Able to implement Earned Value Management techniques and provide earned value metrics in monthly reporting on government contracts a plus • Proficiency in Word, Excel, PowerPoint and Project is required • Able to travel as required to meet with contractors, partners, or project funding entities There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Equipment Specialist is responsible for maintenance and operational support of all equipment and areas needed for the manufacture of parenteral pharmaceuticals at the Baltimore Camden fill/finish facility. Additional duties will include parts and tool management, plant equipment support, parts design, as well as management of moderately sized capital projects. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Comply with cGMP regulations, adhere to company policies, and adhere to SOP and Batch Record directions Assist the Validation with the operation and execution of engineering projects. Provide technical expertise for these projects Provide technical support during manufacturing activities Focus to continually improve processes throughout the manufacturing and packaging areas. Coordinates and performs preventive/reactive maintenance on production and facility equipment Maintains detailed maintenance records Coordinates contracted maintenance activities with vendors Assists in qualification of equipment / facilities as needed Compiles, analyzes, draws conclusions and provides written documentation related to the maintenance and lifecycle of production systems Administers project management controls and reports status to senior management Involved in the oversight and coordination of activities that include design, specification creation, procurement, construction management, repair of production and facilities equipment Researches new technologies and procedures to enhance production and performs engineering design evaluations Applies creative and sound troubleshooting techniques to generate timely solutions to problems Assignments are broad in nature, requiring originality and ingenuity, and rely on collaboration, limited experience and judgment to plan and accomplish goals Assists in programming, maintenance and troubleshooting of programmable logic controllers and process/environmental monitoring systems Establish procedures with some supervision The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS Bachelors in Engineering or equivalent Engineering Technician/Specialist experience consisting of Technical (Trade/ Military) Training 3-5 years of experience in industrial/pharmaceutical engineering/maintenance setting or transitioning military Basic knowledge of electronics systems is essential Knowledge of 2D and/or 3D electronic drafting preferred Must possess the ability to identify and resolve problems in a timely manner while gathering and analyzing information skillfully PLC and process control troubleshooting skills preferred Proven track record of applying broad knowledge of engineering principles, practices and procedures to the completion of moderately difficult assignments Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Position Summary The candidate will provide scientific expertise and leadership for development of analytical methods to support all phases of vaccine product development. Candidate will be highly motivated and exercise a leadership role within the Analytical Development team. The candidate will have supervisory responsibilities to ensure the work is performed within timelines and to high quality standards. The candidate will be responsible for providing strategy, planning, development, and execution of assays to support CMC activities including process development, product characterization, and release and stability testing of early to late phase clinical vaccine drug products. In addition, the candidate will be expected to prepare scientific data presentations, write and review study reports, and laboratory protocols. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Provide leadership and technical direction to the protein characterization group for development and execution of analytical methods for a variety of vaccine candidates. Lead assay development and optimize characterization assays to determine protein physico-chemical properties, activity, identity, purity, and etc. in support of CMC development activities Supervise activities of senior scientists and ensure accountabilities to department and project team objectives. Provide technical strategies for identifying, evaluating and prioritizing the selection of appropriate technologies to implement analytical methods to support vaccine product development. Lead assay optimization and technology transfer to external labs Work closely with project leaders, project managers, and other functional groups (QA, Nonclinical, Regulatory, and Clinical Development) to provide scientific direction and oversight to ensure that project and team needs are met. Serve as an ad hoc scientific resource to other groups and departments as well as the company's project teams Minimum Education, Experience and Skills PhD in Biochemistry, Virology, or Immunology with 10 plus years of related experience. Minimum of 5 years' experience managing a team Wide knowledge of vaccine development and protein characterization methodologies. Extensive knowledge of GMP and CMC regulatory guidance documents. Hands-on experience with state-of the-art methods and instrumentation to support CMC supportive method development. Excellent organization and writing and presentation skills are required. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Assistant General Counsel - Legal Regulatory and Compliance is responsible for managing a breadth of complex global legal regulatory and compliance matters related to commercial vaccines and pharmaceuticals and medical countermeasures products for the Devices, Vaccines, and Therapeutics Business Units by providing practical, timely, strategic and high-quality legal advice to a broad spectrum of clients across the organization. This is a highly strategic position and is accountable for balancing United States and global opportunities with associated legal and compliance risks in a complex and fast-evolving regulatory environment. This position is also accountable for collaborating with other members of the Legal Team and Ethics and Compliance to proactively identify and mitigate regulatory and compliance risks to the Company's ability to achieve its strategic corporate operating plan (COP). ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Assistant General Counsel - Legal Regulatory and Compliance will serve as a strategic legal partner to business unit leaders and their teams by leading and overseeing a range of strategic legal support, advice, and counseling, taking into account the domestic and global objectives of the organization and the unique global, regional and local legal and regulatory requirements. In this regard, the Assistant General Counsel - Legal Regulatory and Compliance will also align, coordinate and work closely with members of the Legal, Ethics & Compliance, Medical Affairs, Regulatory, International medical countermeasures (MCM) procurement, and Global Government Affairs teams as needed or appropriate. Collaborating with intellectual property, commercial, and medical countermeasures attorneys on regulatory and compliance issues in a broad range of complex agreements, including agreements for research and development collaboration, sponsored research, clinical trials, expanded access, compassionate use, patient recruitment, informed consents, non-interventional studies, sponsorships and grants, advisory boards, data sharing and data licensing, investigator-initiated trials, and regulatory, quality, and pharmacovigilance agreements. Leading and/or and overseeing a full range of legal regulatory support for clinical development and medical affairs activities throughout the life cycle of all development programs and products including IND, NDA, and BLA filings and emergency use authorizations. Such support includes providing legal advice, including the legal interpretation of laws, rules, regulations, and guidance documents relating to the development of vaccines, biologics, and other pharmaceutical products. Together with members of the MCM Legal Team, provide legal support to the International MCM Procurement Team and Medical Affairs in support of international procurement of medical countermeasures. Together with other members of the Legal Regulatory and Compliance team, contribute to the establishment of governance and processes to develop a globally consistent approach to Legal Regulatory support taking into account unique aspects required for particular client groups as well as specific legal requirements for the countries in which the commercial products teams and MCM procurement team operate. Representing the Legal department on various senior management cross-functional teams and/or committees. Retaining, supervising and directing outside counsel effectively and efficiently managing legal expenses consistent with the Legal operations budget. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Law Degree from an ABA accredited school and licensed and in good standing in at least one U.S. State At least 10 years of experience working in a law firm and/or pharmaceutical or biotechnology legal department. Deep understanding of the legal issues affecting the pharmaceutical industry, including regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws. Working knowledge of the global regulatory environment. In-depth understanding of the pharmaceutical industry, including IP, manufacturing, R&D, regulatory, and commercial elements. Working knowledge of emergency use authorization, expanded access, compassionate use, and foreign regulatory authority equivalents required. Strong ability to grasp legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment, and provide practical and constructive legal advice in a time-sensitive, dynamic, and fast-paced complex environment. Strong management, teamwork, and leadership skills with a growth mindset, including the ability to effectively work within a matrix team environment. Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. Builds relationships across functions and sites and inspires trust and confidence through effective communication and interpersonal skills. Strong work ethic and ability to manage large workload, focus on critical priorities, and otherwise effectively meet client needs directly and with members of the Legal Regulatory and Compliance team. Defines success in terms of team goals, adapts quickly to changing resource requirements, has a clear understanding of other groups' business priorities, and uses knowledge of organizational culture to achieve objectives. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. Job Summary The Regulatory Affairs Manager will support regulatory activities for Vaccines Business Unit as the regulatory representative on assigned Product Team(s). He/she will work with functional line management and team members across multiple disciplines including nonclinical, clinical and CMC to develop regulatory strategies and manage regulatory submission activities. The RA manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as planning and executing meetings with regulatory agencies. Essential Functions • Represent Regulatory Affairs as the SME on assigned product/ project teams and ensure timely communication of regulatory strategy and plans to team members and line management • Develop regulatory strategy for assigned products and/or country • Plan and coordinate the preparation of regulatory submissions including meetings with health authorities and routine correspondence • Provide critical review of all documentation supporting regulatory applications • Provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management • Plan, coordinate, prepare and support meetings and teleconferences with regulatory agencies and submission meetings; may also be required to work with government funding agencies • Prepare responses to complex questions and comments from regulatory agencies • Ensure regulatory product compliance for product (e.g. agency commitments) • As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance • Conduct and analyze regulatory research to understand competitor activity • Interact with company partners and consultants for various regulatory matters as needed • As required, develop procedures to support the regulatory affairs department • Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to assigned programs. Interpret existing regulations and guidance documents for regulatory department and/or project teams • May be responsible for a functional area and/or have direct reports The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Minimum Education, Experience, Skills • Bachelor's degree in a life sciences or related discipline required. Approximately 8+ years of relevant pharmaceutical industry experience, with minimum 5 years in Regulatory Affairs. Less experience acceptable for suitable candidates with relevant industry experience and skill sets. • Must have experience interacting with the FDA, EMA, Health Canada and/or other agencies as required • Ability to work on problems of diverse scope • Identifies priorities and key issues in complex situations and solves with minimal assistance • Exercises judgement within generally defined regulatory practices and policies • Experienced in leading cross-functional interactions related to regulatory matters • Effective in both written and oral communication • Is able to direct work as required and manage complexity • Thorough knowledge of the development of one or more types of Health Authority regulated products (drugs, biologics, medical devices, combination products) • Ability to anticipate and prevent potential issues • Understanding of regulatory issues and their touch points There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I: Job Summary The technical evaluation and proposals (TE&P) team is a critical function within the Commercial Operations group of Emergent's CDMO business unit across biologics development services, drug substance manufacturing, drug product manufacturing for mammalian, microbial, viral, plasma and advanced therapies. The TE&P team is responsible for commercial analysis and execution of the project acquisition, specifically the comprehensive understanding the project proposal, estimate, and technical inquiry requests for current and potential clients and translating these requests into timely and technically sound response that accurately conveys Emergent's technical capabilities and value proposition. The position of Director, Technical Evaluation and Proposals will lead this established team in a 'player - coach' role, with responsibility for the overall execution, organization, evolution, expertise and competence of this group. Additionally, the incumbent is expected to routinely step in to a hands-on role to support critical and/or high-profile project proposals or surge response capacity as required. This position will coach and mentor individual team members within the group, as well as lead initiatives for continuous improvement in the overall process and flow from quote request through to the final document revision, including technical, operational and financial queries, and responsibility for data integrity of the projects in online commercial operations databases. This includes: • Direct interaction with clients to properly understand and scope the technical request, execution of a response strategy developed in conjunction with Sales & Business Development (S&BD), Commercial Development (CD) directors, and site SMEs/operational leaders as required, interfacing with site SMEs for evaluation of any nonstandard technical requests, working with finance to develop cost models and with S&BD/CD to establish pricing, and obtaining all necessary internal approvals required for proposal generation; including but not limited to operations, legal, and finance • Lead the development of the future state technical evaluation and proposal process, system, etc to ensure continuous improvement but also scalability including automation • Manage the commercial analysis function and supporting the CDMO Business Unit This team must have a broad understanding of all key stakeholder functions required to evaluate, respond to, and execute upon a potential project, and is expected to be able to thoroughly articulate Emergent's technical capabilities for the majority of client inquiries. In particular, the TE&P team must be able to speak fluently to technical capabilities and approach for all Emergent CDMO assets to internal and external stakeholders. The commercial analysis function within the team will design and support the implementation of business processes to track, manage and report on key project metrics for the CDMO portfolio and pipeline. It will analyze the entire project acquisition process to facilitate performance tracking and BU decision making on commercial strategy within each service line (DVS, DS and DP), including advising the Commercial Development leaders of each service line and S&BD leadership on setting revenue and margin targets for sites, systems, assets and the sales team members and monitoring performance against these objectives. This individual is responsible for the creation and implementation of cross-functional analytical tools used in continuous, proactive analysis of the CDMO portfolio. II. Responsibilities • Ensure accurate and timely delivery of proposals to the S&BD team • Organize and facilitate project planning, review, and technical meetings with stakeholders and clients as required • Prioritize workflow for individuals and the overall team as necessary; implement and lead routine workflow review meetings with TE&P team • Communicate drafting progress and upcoming review requirements to proposal stakeholders- S&BD account managers, CD directors, reviewers, site SMEs, BU leadership • Develop and utilize a strong working knowledge of Emergent's CDMO capabilities across the organization's network of manufacturing and development sites • Work closely with Commercial Development directors to align on response and project win strategies, as well as support information flow on project strategy to sites/manufacturing operations on an ongoing basis • Review and approve all proposals for content and accuracy prior to submission to S&BD • Ensure appropriate approvals are secured for documents prior to client distribution • Coach and develop team members • Develop the technical evaluation function and content libraries of technical details and capabilities • Continue evolution of project acquisition process and implementation of best practices to 'win' at the proposal process • Ensures CRM data integrity and system utilization • Weekly reporting on proposal progression for CD reporting and business reviews • Backfill for team members when necessary, provide surge capacity in proposal drafting III: Education, Experience & Skills • Bachelor's degree required in relevant technical discipline; master's degree or higher preferred • Technical expertise in drug substance manufacturing, drug product manufacturing and process/analytical development services in the biologics sector is a must • Minimum of 10 years of relevant experience in the CDMO industry in proposal development, sales operations, or equivalent role • Experience with best practices in proposal development and workflow • CRM (ie SalesForce) and analytics experience • Project Management experience would be considered an asset • Proven capability to collaborate across organizational boundaries and influencing without authority. • Ability to develop and deliver multi-mode communications that convey a clear understanding of the unique needs of different audiences (including to our senior leaders, clients, and cross-functional, international teams). • Excellent written communication and persuasive writing skills required. • Excellent organizational, project management, and prioritization skills. • Proven capability to manage multiple, complex projects, meeting tight deadlines, and working well in high stakes situations. • Attention to detail required. • Extensive familiarity with the Microsoft product suite is required. • Experience with proposal development /collaboration software including Sharepoint and XaitPorter There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY Supervision and oversight of routine and non-routine microbiological activities. This includes scheduling and execution of the environmental monitoring testing program, utility testing program, raw material, in-process, and product release testing requirements and well as ensuring adequate resources to support non-routine method qualification, area re-qualification, growth promotion, and reagent control activities. This is a 2nd shift position, Monday -Friday 2pm-10:30pm. ESSENTIAL FUNCTIONS Responsible for scheduling, execution and quality documentation of the environmental monitoring program. Provides support for alert and action level event investigations. Responsible for scheduling, execution and quality documentation of the utility monitoring program. Provides support for alert and action level event investigations Responsible for scheduling, execution and quality documentation of raw material, in-process, and product release testing. Provides support for alert and action level event investigations Provide process monitoring support for aseptic processes. Responsible for scheduling and execution of test data review in a timely manner Ensure equipment and materials needed to support environmental and utility monitoring programs are procured, tested and available for use. Ensure that lab activities are conducted according to safety guidelines, policies and legislation. Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need. Perform administrative duties such as approval of time documentation. Responsible for professional development, goal setting and performance review of lab staff. Provide technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments. Provide information in support of department budget. Contribute to departmental strategy and provide input on lab requirements and improvements. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. MINIMUM EDUCATION, EXPERIENCE, SKILLS University degree in chemistry, biology or related field of study. Minimum of five years directly related experience in a recognized professional or technical/scientific field, with experience in a leadership or supervisory role. Experience in an operating in pharmaceutical cGMP environment is required. Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports. Proficient and professional communicator, verbally and in writing. Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions. Strong organizational and interpersonal skills and the ability to work collaboratively with others. Proficient in complex procedures and problem solving. Strong commitment to teamwork, proven leadership skills, independence and initiative. Proficient in Microsoft Office - Word, Excel, PowerPoint Comprehensive knowledge of pharmaceutical GLPs and GMPs Comprehensive knowledge of laboratory techniques and safety precautions Experience with LIMS and SAP software applications is desired. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. I: Job Summary The Specialist II will provide a broad scope of technical knowledge to independently analyze risk, troubleshoot highly complex issues, support quality systems and plant compliance. They apply expertise and regulatory knowledge to support change and risk management, including application of scientific and technical innovation as it pertains to Commercial Manufacturing. The Specialist II develops a lifecycle and systems-based approach to the design and implementation of Commercial Quality Systems and process controls. This role frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and cross-functional peers to gain alignment on sound quality decisions on both clinical and commercial GMP-related issues. II: Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. General Critically review various types of documentation to ensure completeness, accuracy, and compliance including but not limited to regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request For Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls Review/support contract negotiations for potential customers (specific to review of sections pertaining to compliance) Host and help manage Regulatory and Client Audits, responses and associated CAPA. Supplier Quality Manage Supplier Quality Program Develop and revise Quality Agreements as applicable for suppliers providing products or services in support of GMP operations Manage supplier notification changes to ensure impact is thoroughly assessed prior to implementation Liaise with suppliers in addressing nonconformities through thorough investigations. Maintain a Supplier Corrective Action process and liase with suppliers to resolve quality issues. Compliance Recognize and promote quality and compliance improvement Plan, schedule and conduct internal quality system audits per audit schedule. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes and activities in creating the audit plan Drive inspection readiness strategy and activities and serve as a subject matter expert in quality systems Develop and lead Product Complaint Program Develop and lead Product Recall Program Contribute to management of Annual Product Review Contribute to the drafting and review of regulatory submissions Quality Systems Maintain Emergent's Quality Systems including but not limited to CAPAs, Change Control, Effectiveness Checks and Management Review in support of manufacturing operations Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III: Minimum Education, Experience & Skills Bachelor's Degree in Scientific or related fields preferred A minimum of six (6) years of cGMP Quality experience Strong Commercial manufacturing experience (Large Molecules) required Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards Expert Knowledge and application of GMP principles Excellent communication skills: oral/written and listening Excellent facilitation and presentation skills Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability, decision making, coaching, Interpersonal skills: team building, consensus building, conflict resolution Critical analytical skills, strong verbal and communication skills Must be able to critically evaluate data summaries and conclusions Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }