Job Description: PURPOSE AND SCOPE OF POSITION: The Manufacturing Applications Administrator works cross-functionally to support the administration of IT GxP systems and applications onsite. This role is an individual contributor and will partner with Business Owners, Technical Owners and Quality to support GxP systems and applications as well as cybersecurity fundamentals. This role will support daily operations and make improvements to and offering advice about installations, configurations, and governing procedures. Education: Bachelor's degree in a life sciences or IT discipline or a minimum of 3 years of equivalent IT experience. Experience: 3+ years of direct experience with Manufacturing Applications Administration for solutions in a GxP environment is required Experience with Active Directory Domain Services Understanding of Microsoft Windows Server versions 2012 and 2016 Knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records, and electronic signatures Understanding of patching and cybersecurity fundamentals Strong communication and problem-solving skills with a focus on achievement of overall goals Proven success working well in a team environment with flexibility to react to changing business needs Ability to work independently and remotely with minimum direct supervision DUTIES AND RESPONSIBILITIES: Administer Manufacturing Applications and work with local site and global teams to align multiplatform environment. Coordinate with global IT Teams in integration activities across sites, domains and environments. Act as POC with Global IT Cybersecurity and coordinate cyber project implementations protecting Bothell (JuMP) Manufacturing site Perform the following Cybersecurity activities: Network and Server monitoring Firewall and remote access implementations and management Patching and Antivirus distribution and deployment Support Windows O/S patching Support Periodic monitoring and reviews of System Audit trails and User Accounts Author and update Admin SOPs Participate in Change Management processes Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures Ensure the validation of computerized systems used across GxP operations is conducted in compliance with applicable regulatory requirements and internal procedures Additional Job Requirements: None
01/28/2021
Full time
Job Description: PURPOSE AND SCOPE OF POSITION: The Manufacturing Applications Administrator works cross-functionally to support the administration of IT GxP systems and applications onsite. This role is an individual contributor and will partner with Business Owners, Technical Owners and Quality to support GxP systems and applications as well as cybersecurity fundamentals. This role will support daily operations and make improvements to and offering advice about installations, configurations, and governing procedures. Education: Bachelor's degree in a life sciences or IT discipline or a minimum of 3 years of equivalent IT experience. Experience: 3+ years of direct experience with Manufacturing Applications Administration for solutions in a GxP environment is required Experience with Active Directory Domain Services Understanding of Microsoft Windows Server versions 2012 and 2016 Knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records, and electronic signatures Understanding of patching and cybersecurity fundamentals Strong communication and problem-solving skills with a focus on achievement of overall goals Proven success working well in a team environment with flexibility to react to changing business needs Ability to work independently and remotely with minimum direct supervision DUTIES AND RESPONSIBILITIES: Administer Manufacturing Applications and work with local site and global teams to align multiplatform environment. Coordinate with global IT Teams in integration activities across sites, domains and environments. Act as POC with Global IT Cybersecurity and coordinate cyber project implementations protecting Bothell (JuMP) Manufacturing site Perform the following Cybersecurity activities: Network and Server monitoring Firewall and remote access implementations and management Patching and Antivirus distribution and deployment Support Windows O/S patching Support Periodic monitoring and reviews of System Audit trails and User Accounts Author and update Admin SOPs Participate in Change Management processes Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures Ensure the validation of computerized systems used across GxP operations is conducted in compliance with applicable regulatory requirements and internal procedures Additional Job Requirements: None
Immediate need for a Job title Instrumentation and Controls (I&C) Engineer e xperience in the Pharmaceutical Industry . This is 12+ Months Contract position for the location Allston, MA ( half on site and half remote.) . Please review the job description below: Job ID # 21-03077 This role will be half on site and half remote. The I&C Engineering Team at the Allston Landing manufacturing site is responsible for ensuring that the instruments and controls on manufacturing equipment/systems and automation systems used in the manufacture, storage, testing, and distribution of *** products are functional, safe, and fit for purpose in accordance with *** corporate standards and industry regulatory requirements. Responsibilities may include identifying and implementing new or revised instrumentation and controls, supporting verification and validation of the asset, providing maintenance and technical support of the asset in its commissioned/ qualified/ validated state, and decommissioning the asset at the end of its life. General duties include: • Provide technical support for plant process control equipment and engineers. Individual will be actively involved in daily operations when required to meet schedules or to resolve manufacturing challenges. • Lead efforts with engineering, manufacturing, process automation, facilities maintenance, manufacturing science and technology, quality assurance, and other departments in resolving issues, developing requirements, and providing recommendations for system modifications. • Execute technical tasks in the design, development, implementation, and documentation of process automation/control projects. • Perform assignments that have loosely defined objectives that require investigation of a large number of variables. • Actively participate and provide input for the *** Safety Program to meet Health and Safety regulations and OSHA requirements in all duties. Individual should have direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working knowledge of pharmaceutical/biotech processes and associated utility systems. This role requires the ability to work in cross-functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members. Requires Bachelor's Degree/Undergraduate Degree or Advanced Degree in Electrical Engineering, Mechanical Engineering, or related technological field. Years of Experience: 6 - 9 Years Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration. #Mor
01/25/2021
Full time
Immediate need for a Job title Instrumentation and Controls (I&C) Engineer e xperience in the Pharmaceutical Industry . This is 12+ Months Contract position for the location Allston, MA ( half on site and half remote.) . Please review the job description below: Job ID # 21-03077 This role will be half on site and half remote. The I&C Engineering Team at the Allston Landing manufacturing site is responsible for ensuring that the instruments and controls on manufacturing equipment/systems and automation systems used in the manufacture, storage, testing, and distribution of *** products are functional, safe, and fit for purpose in accordance with *** corporate standards and industry regulatory requirements. Responsibilities may include identifying and implementing new or revised instrumentation and controls, supporting verification and validation of the asset, providing maintenance and technical support of the asset in its commissioned/ qualified/ validated state, and decommissioning the asset at the end of its life. General duties include: • Provide technical support for plant process control equipment and engineers. Individual will be actively involved in daily operations when required to meet schedules or to resolve manufacturing challenges. • Lead efforts with engineering, manufacturing, process automation, facilities maintenance, manufacturing science and technology, quality assurance, and other departments in resolving issues, developing requirements, and providing recommendations for system modifications. • Execute technical tasks in the design, development, implementation, and documentation of process automation/control projects. • Perform assignments that have loosely defined objectives that require investigation of a large number of variables. • Actively participate and provide input for the *** Safety Program to meet Health and Safety regulations and OSHA requirements in all duties. Individual should have direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working knowledge of pharmaceutical/biotech processes and associated utility systems. This role requires the ability to work in cross-functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members. Requires Bachelor's Degree/Undergraduate Degree or Advanced Degree in Electrical Engineering, Mechanical Engineering, or related technological field. Years of Experience: 6 - 9 Years Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration. #Mor
Immediate need for a Job title Biologic Material Scientist or Technical Steward e xperience in the Pharmaceutical Industry . This is 6 + Months Contract position for the location Frederick, MD. Please review the job description below: Job ID # 21-03031 Experience with GMP manufacturing at a biologics or pharmaceutical manufacturing facility. Someone who can bridge the gap between the teams using the raw biologic materials and the vendors selling AZ the materials. Someone who can collaborate with partners within the regulatory affairs department to ensure AZ remains compliant. Strong documentation experience with quality assurance, but has a laboratory background specifically with cell culture processes and testing. An energetic, self-motivated and innovative individual who possesses skills required to successfully develop and execute project tasks and deliverables, be a collaborative team player and have a strong drive to deliver to customers. Overview of Role: This resource will work with the product raw material procurement and technical teams to define & assess requirements for raw materials and product contact materials. It is the responsibility of this resource to ensure that the process materials meet established industry requirements, such as biopharmaceutical grade, adventitious agent controls, leachable & extractable, dual sourcing, etc. This effort requires interactions with multidisciplinary and multisite groups, which may include technology transfer teams, external vendors and other strategic suppliers. REQUIREMENTS Minimum Education: o B.S. in Engineering, Biological/Physical Sciences, or equivalent focus of study with 5 years' experience, or o M.S with 3 years' experience Experience Required: o Full use and application of principles, theories, concepts and techniques in a limited area or field. o Able to work on multiple projects and meet deadlines as needed o Demonstrate good oral and written skills. o Experience with GMP manufacturing at a biologics or pharmaceutical manufacturing facility. o The resource must establish relationships with Validation, Engineering, Development, CMOs, Supply Chain, Quality, Regulatory and others in Operations Job Responsibilities & Accountabilities: • Evaluate the material attributes, structures and properties, such as composition, product compatibility, and comparability in order to obtain information to determine whether materials are acceptable for GMP use • Define/ recommend conditions for material use for reliable performance in various environments. • Assess Certificate of Analysis and additional testing methods (if any) to confirm/ evaluate the effects when used as second sourcing options in various manufacturing processes on particular AZ products. • If required by risk assessment, plan laboratory qualification experiments and/or material attribute assessments to confirm feasibility of processes and techniques used in the production of materials having special characteristics. • Prepare reports of materials study findings for the use of other scientists and requestors. • Test material samples for further functional test capabilities, to further support feasibility for utilization. Therefore, work at the MS&T laboratories will be required; Contractor should be capable to train in lab procedures and specifically, cell culture processes and testing, to better understand what to consider in the material 2nd source. • Assess material's supplier production processes to ensure that materials are manufactured to meet technical and quality specifications in order to be used efficiently and that the project is completed within appropriate time frames and budget. • When required, test individual parts and products in order to ensure that manufacturer and quality and safety standards are met. • Stay abreast of the latest technologies used in Biologics with the awareness of the cost of various technologies • Savvy in the utilization of change management and risk base assessment processes • May participate in vendor interactions/visits of potential drug substance companies; equipment and material suppliers; and support due diligences • Might provide technical support for product/process materials and investigations throughout product lifecycle • Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of noncompliance. • Manages a cross-functional team or internationally in own field of specialism. Role requires a high level of interactive communication to set clear direction for the cross functional team and directly advising others at a high level, as well as cultural sensitivity. Manages high level risk by making complex judgements, developing innovative solutions and applying a comprehensive cross-functional and industry understanding. Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration. #Mor
01/24/2021
Full time
Immediate need for a Job title Biologic Material Scientist or Technical Steward e xperience in the Pharmaceutical Industry . This is 6 + Months Contract position for the location Frederick, MD. Please review the job description below: Job ID # 21-03031 Experience with GMP manufacturing at a biologics or pharmaceutical manufacturing facility. Someone who can bridge the gap between the teams using the raw biologic materials and the vendors selling AZ the materials. Someone who can collaborate with partners within the regulatory affairs department to ensure AZ remains compliant. Strong documentation experience with quality assurance, but has a laboratory background specifically with cell culture processes and testing. An energetic, self-motivated and innovative individual who possesses skills required to successfully develop and execute project tasks and deliverables, be a collaborative team player and have a strong drive to deliver to customers. Overview of Role: This resource will work with the product raw material procurement and technical teams to define & assess requirements for raw materials and product contact materials. It is the responsibility of this resource to ensure that the process materials meet established industry requirements, such as biopharmaceutical grade, adventitious agent controls, leachable & extractable, dual sourcing, etc. This effort requires interactions with multidisciplinary and multisite groups, which may include technology transfer teams, external vendors and other strategic suppliers. REQUIREMENTS Minimum Education: o B.S. in Engineering, Biological/Physical Sciences, or equivalent focus of study with 5 years' experience, or o M.S with 3 years' experience Experience Required: o Full use and application of principles, theories, concepts and techniques in a limited area or field. o Able to work on multiple projects and meet deadlines as needed o Demonstrate good oral and written skills. o Experience with GMP manufacturing at a biologics or pharmaceutical manufacturing facility. o The resource must establish relationships with Validation, Engineering, Development, CMOs, Supply Chain, Quality, Regulatory and others in Operations Job Responsibilities & Accountabilities: • Evaluate the material attributes, structures and properties, such as composition, product compatibility, and comparability in order to obtain information to determine whether materials are acceptable for GMP use • Define/ recommend conditions for material use for reliable performance in various environments. • Assess Certificate of Analysis and additional testing methods (if any) to confirm/ evaluate the effects when used as second sourcing options in various manufacturing processes on particular AZ products. • If required by risk assessment, plan laboratory qualification experiments and/or material attribute assessments to confirm feasibility of processes and techniques used in the production of materials having special characteristics. • Prepare reports of materials study findings for the use of other scientists and requestors. • Test material samples for further functional test capabilities, to further support feasibility for utilization. Therefore, work at the MS&T laboratories will be required; Contractor should be capable to train in lab procedures and specifically, cell culture processes and testing, to better understand what to consider in the material 2nd source. • Assess material's supplier production processes to ensure that materials are manufactured to meet technical and quality specifications in order to be used efficiently and that the project is completed within appropriate time frames and budget. • When required, test individual parts and products in order to ensure that manufacturer and quality and safety standards are met. • Stay abreast of the latest technologies used in Biologics with the awareness of the cost of various technologies • Savvy in the utilization of change management and risk base assessment processes • May participate in vendor interactions/visits of potential drug substance companies; equipment and material suppliers; and support due diligences • Might provide technical support for product/process materials and investigations throughout product lifecycle • Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of noncompliance. • Manages a cross-functional team or internationally in own field of specialism. Role requires a high level of interactive communication to set clear direction for the cross functional team and directly advising others at a high level, as well as cultural sensitivity. Manages high level risk by making complex judgements, developing innovative solutions and applying a comprehensive cross-functional and industry understanding. Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration. #Mor
Immediate need for a Job title Formulation Scientist e xperience in the Pharmaceutical Industry . This is6 + Months Contract position for the location Andover, MA . Please review the job description below: Job ID # 21-02421 open to levels I and II The individual in this role will be a highly skilled, meticulous and motivated scientist who will focus on analytical characterization of mRNA and Lipid Nanoparticle (LNP) formulations. He/she will work cross-functionally to design and coordinate analytical characterization characterize and/or implement fit-for-purpose, robust, characterization methods Identify, develop and implement Client biochemical and biophysical methods to further enhance knowledge or to address potential analytical characterization gaps for mRNA and Lipid Nanoparticles He/she will participate in performing biochemical and biophysical characterization (HPLC, cIEF, light scattering, particle characterization, spectroscopy, calorimetry) of lipid nanoparticles, lipids and mRNA. Preparation of samples for characterization studies • Perform analytical testing supporting process development and product release, including spectroscopic, chromatographic, biophysical, and molecular biology techniques Maintain thorough electronic lab notebooks and documentation records Deliver reproducible and impactful results under ambitious timelines • Execute and troubleshoot standard protocols, develop and adapt new protocols into practice, and query literature to incorporate additional assays as needed. Position Comments visible to MSP and Supplier: Intake Notes: Job description has been updated General Analytics Particle Characterization MRNA - experience BS w/0-6yrs MS w/0-2 Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration Job Requirements: Responsibilities: open to levels I and II The individual in this role will be a highly skilled, meticulous and motivated scientist who will focus on analytical characterization of mRNA and Lipid Nanoparticle (LNP) formulations. He/she will work cross-functionally to design and coordinate analytical characterization characterize and/or implement fit-for-purpose, robust, characterization methods Identify, develop and implement Client biochemical and biophysical methods to further enhance knowledge or to address potential analytical characterization gaps for mRNA and Lipid Nanoparticles He/she will participate in performing biochemical and biophysical characterization (HPLC, cIEF, light scattering, particle characterization, spectroscopy, calorimetry) of lipid nanoparticles, lipids and mRNA. Preparation of samples for characterization studies • Perform analytical testing supporting process development and product release, including spectroscopic, chromatographic, biophysical, and molecular biology techniques Maintain thorough electronic lab notebooks and documentation records Deliver reproducible and impactful results under ambitious timelines • Execute and troubleshoot standard protocols, develop and adapt new protocols into practice, and query literature to incorporate additional assays as needed. General Analytics Particle Characterization MRNA - experience BS w/0-6yrs MS w/0-2
01/23/2021
Full time
Immediate need for a Job title Formulation Scientist e xperience in the Pharmaceutical Industry . This is6 + Months Contract position for the location Andover, MA . Please review the job description below: Job ID # 21-02421 open to levels I and II The individual in this role will be a highly skilled, meticulous and motivated scientist who will focus on analytical characterization of mRNA and Lipid Nanoparticle (LNP) formulations. He/she will work cross-functionally to design and coordinate analytical characterization characterize and/or implement fit-for-purpose, robust, characterization methods Identify, develop and implement Client biochemical and biophysical methods to further enhance knowledge or to address potential analytical characterization gaps for mRNA and Lipid Nanoparticles He/she will participate in performing biochemical and biophysical characterization (HPLC, cIEF, light scattering, particle characterization, spectroscopy, calorimetry) of lipid nanoparticles, lipids and mRNA. Preparation of samples for characterization studies • Perform analytical testing supporting process development and product release, including spectroscopic, chromatographic, biophysical, and molecular biology techniques Maintain thorough electronic lab notebooks and documentation records Deliver reproducible and impactful results under ambitious timelines • Execute and troubleshoot standard protocols, develop and adapt new protocols into practice, and query literature to incorporate additional assays as needed. Position Comments visible to MSP and Supplier: Intake Notes: Job description has been updated General Analytics Particle Characterization MRNA - experience BS w/0-6yrs MS w/0-2 Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration Job Requirements: Responsibilities: open to levels I and II The individual in this role will be a highly skilled, meticulous and motivated scientist who will focus on analytical characterization of mRNA and Lipid Nanoparticle (LNP) formulations. He/she will work cross-functionally to design and coordinate analytical characterization characterize and/or implement fit-for-purpose, robust, characterization methods Identify, develop and implement Client biochemical and biophysical methods to further enhance knowledge or to address potential analytical characterization gaps for mRNA and Lipid Nanoparticles He/she will participate in performing biochemical and biophysical characterization (HPLC, cIEF, light scattering, particle characterization, spectroscopy, calorimetry) of lipid nanoparticles, lipids and mRNA. Preparation of samples for characterization studies • Perform analytical testing supporting process development and product release, including spectroscopic, chromatographic, biophysical, and molecular biology techniques Maintain thorough electronic lab notebooks and documentation records Deliver reproducible and impactful results under ambitious timelines • Execute and troubleshoot standard protocols, develop and adapt new protocols into practice, and query literature to incorporate additional assays as needed. General Analytics Particle Characterization MRNA - experience BS w/0-6yrs MS w/0-2