Senior Specialist, Manufacturing Operations
2 weeks ago
Job DescriptionThe Manufacturing Operations Senior Specialist serves in a project lead role within Cell Manufacturing. This position is responsible for driving projects to completion within the GMP cell processing operations team. The incumbent will have expertise in cell culture and GMP as well as exceptional project management skills. The work schedule for this position is Wednesday-Saturday, 2nd shift (12:30 pm - 11 pm) for a total of 40 hours/week. Key Duties and Responsibilities: • Perform clinical product manufacturing for cell therapy according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, reporting deviations • Provides experience-related information to drive more efficient technology transfer and final process development from the Development to the Manufacturing group. Assists in the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with Research and Quality Systems groups • Ensures cGMP compliance through manufacturing oversight and tracking • Monitors scheduling and assists with coordinating resources such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities • Manage individual projects, including managing timelines and leading small group meetings • Receive and manage equipment alarms • Serves as the main technical SME for the team, troubleshoots problems independently • Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking. • Other duties and projects as assign as required to meet departmental requirements Knowledge and Skills: • Minimum of 3 years cell culture experience, ideally in both adherent and suspension cultures • Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems • Extensive experience with technical writing • Minimum 6 years working experience in relevant field (may be reduced based on education level) • Extensive GMP experience, including as a lead or trainer • Expertise in cell processing technologies for clinical production • Experience with bioreactors for cell culture • Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820) Environment: • Works in a cleanroom and office setting • Must be able to remain in a stationary position 50% during processing activities • Frequently move about inside the cleanroom to accomplish process tasks • Occasionally moves lab equipment and materials weighing up to 50 pounds. • Compressed gasses and LN2 are used in this process Flex Designation:On-Site DesignatedFlex Eligibility Status:In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
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Senior Specialist, GMP Operational Quality
1 hour ago
Boston, United States Katalyst HealthCares & Life Sciences Full timeJob Description: Developing Quality Documents. Small Molecule Manufacturing. The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activities to support developmental programs. The Senior Specialist supports or...
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Senior Specialist, GMP Operational Quality
4 weeks ago
Boston, United States Katalyst Healthcares & Life Sciences Full timeSenior Specialist Quality AssuranceDeveloping quality documents in small molecule manufacturing. The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activities to support developmental programs. The Senior...
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Boston, United States Planet Pharma Full timeSenior Manager, External Manufacturing Operations Base pay range: $185,000.00/yr - $195,000.00/yr DIRECT HIRE MUST HAVES: 10+ years of experience w/ a B.S.; 7+ years of experience w/ M.S. or higher MUST HAVE Small Molecule experience (5+ years) MUST HAVE External Manufacturing experience (5+ years) Must have experience working with / managing CDMO or...
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Senior Specialist GMP Operational Quality
2 days ago
Boston, United States Vertex Full timeJob DescriptionGeneral Summary:The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and...
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Operational Quality Senior Specialist
2 weeks ago
Boston, Massachusetts, United States Planet Pharma Full time $72,000 - $93,600 per yearJob DescriptionGeneral Summary:The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and...
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Operational Specialist
4 weeks ago
Boston, United States SD BIOSENSOR HEALTHCARE PVT. LTD. Full timeCompany Description SD BIOSENSOR is a global leader in in‑vitro diagnostics, dedicated to enhancing the quality of life through advanced, accurate, and timely disease diagnosis. Specializing in rapid tests, molecular diagnostics, and other healthcare solutions, we provide tools that empower both patients and healthcare providers. Our commitment to...
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Senior Director of Global Manufacturing
1 day ago
Boston, United States DSJ Global Full timeExecutive Search Consultant - Technical Operations at DSJ Global Base pay range $250,000.00/yr - $300,000.00/yr Position Overview The Senior Director of Global Manufacturing will lead the strategic and operational direction of worldwide manufacturing activities for electronic devices. This role is responsible for ensuring high-quality production, cost...
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Operations Consultant
3 weeks ago
Boston, United States Lime Talent Full timeOperations Consultant – Manufacturing Excellence Base pay range: $100,000.00/yr - $112,000.00/yr Travel – Consultants travel domestically every week from Monday‑Thursday, please note this is a requirement of this role Career Development – Fantastic career development opportunities, this client has a culture fostered around people development About...
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Senior Director of Global Manufacturing
1 day ago
Boston, United States DSJ Global Full timePosition Overview The Senior Director of Global Manufacturing will lead the strategic and operational direction of worldwide manufacturing activities for electronic devices. This role is responsible for ensuring high-quality production, cost efficiency, and scalability across multiple global sites while driving continuous improvement and innovation in...
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Operations Consultant
4 weeks ago
Boston, United States Lime Talent Full timeSalary Details & Other Key Info Base Salary range - $100,000 - $112,000 Strong Bonus + Benefits package Office Location – Boston Travel – Consultants travel domestically every week from Monday-Thursday, please note this is a requirement of this role Career Development – Fantastic career development opportunities, this client has a culture fostered...
