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Biologics Manufacturing Engineer
2 weeks ago
The Fountain Group Durham, United StatesJob Description · Job DescriptionW2 only no C2C · Pay: $45.00 · Job Description: · The ideal candidate possesses experience in Biomanufacturing with an Engineering mind. You will play a critical supportive role to the Engineering team in creating and refining processes in order t ...
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Biogen Durham, United StatesAbout this role The Quality Assurance Manager Biologics Manufacturing is a fully onsite role responsible for strategic leadership of the Quality Factory Team for small and flexible volume manufacturing providing operational oversight of batch product Quality Assurance, Manufactur ...
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Biogen Durham, United StatesJob Description · This position will work alongside a Swing Shift Quality team and will work from 12 PM to 12 AM on a 2,2,3 schedule. · What You'll Do · As a Sr. Supervisor Biologics Manufacturing at Biogen's Research Triangle Park (RTP) facility, you'll be a pivotal part of our ...
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Biogen Durham, United StatesAbout this role The Quality Assurance Sr Manager Biologics Manufacturing is a fully onsite role responsible for strategic leadership of the Quality Factory Team for large volume manufacturing providing operational oversight of batch production activi Quality Assurance, Manufactur ...
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Documentation Specialist
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Insight Global Durham, United StatesMust Haves: · Bachelor's Degree in Science or related field · 2+ years of experience in Quality or Documentation · Reviewing cGMP documentation · Knowledge of manufacturing processes for biologics, vaccines, cell or gene therapy products · Pluses: · Experience with Veeva eQMS or ...
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MSAT Engineer II
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Process Excellence Analyst
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Histology Technician I
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Histology Technician III
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Histology Technician
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Charles River Laboratories, Inc. Durham, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
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Senior Manager, Regulatory CMC Lead
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Sr. Engineer I, Manufacturing
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Associate II, Quality Assurance Biologics
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Biogen Durham, United StatesThe Associate II, Quality Assurance Biologics will perform a wide variety of activities to ensure the quality and safety of our products. Primarily, this role provides on-the-floor quality oversight of GMP manufacturing activities. Those activities i Quality Assurance, Assurance, ...
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QC Microbiologist
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Environmental Monitoring Specialist
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Microbiology Associate
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QC Microbiologist
1 week ago
Piper Companies Durham, United StatesPiper Companies · is currently seeking a · QC Microbiologist · for an opportunity in · Durham, North Carolina (NC), · to join a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines. · Responsibilities of the QC Microbiologist · Contribut ...
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Sr. Engineer I, Manufacturing
2 weeks ago
Biogen Durham, United StatesJob Description · About This Role · The Manufacturing Sr Engineer I designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area suc ...
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Beam Therapeutics Inc. Durham, United StatesPosition Overview: · The Vice President, Global Validation and Process Performance Qualification will be responsible for the overall establishment of Beam's Global Validation Program for Process Performance Qualification (PPQ) / Continuous Process Verification (CPV), creation of ...
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Junior Industrial Engineer
1 day ago
Biogen Durham, United StatesAbout This Role The Global Engineering and Facilities organization is looking to hire a Junior Industrial Engineer. This individual contributor within one on of our functions (Biologics & Advanced Therapies, Fill Finish or ASO/ Small molecule) is res Industrial Engineer, Industri ...
Manager, Quality Assurance Biologics Manufacturing - Durham, United States - Biogen
Description
Job DescriptionAbout this role
The Quality Assurance Manager Biologics Manufacturing is a fully onsite role responsible for strategic leadership of the Quality Factory Team for small and flexible volume manufacturing providing operational oversight of batch production activities and evaluation, as well as providing batch acceptance decisions for production batches at the Biogen Research Triangle Park (RTP) facilities.
This includes direct management of personnel performing routine QA coordination and oversight between Biogen facilities.What You'll Do
Ensures Product Disposition documentation and other documents supporting batch disposition are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
Directs, leads, coordinates, and supports the activities of QA personnel to ensure that all activities are focused upon high productivity and the utmost technical integrity.
Provides mentorship and training within and across functions. Oversees and leads the QA team to provide quality/compliance support and expert guidance to manufacturing operations.Assists QA Management in additional responsibilities related to the daily implementation of the Quality Management Systems required to maintain cGMP compliance and ensure the safety, efficacy and purity of the products Biogen manufactures.
Supports Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required.
Who You Are
You have a track record in leading teams in Quality Assurance and you thrive on leading your team to meet production and compliance guidelines.
Qualifications
Qualifications
BA or BS in scientific field with 5-7 years' in Quality or deep familiarity with Quality requirements through hands-on experience in pharmaceutical or biotech manufacturing OR MS in scientific field with 3-5 years' in Quality or deep familiarity with Quality requirements through hands-on experience in pharmaceutical or biotech manufacturing OR PhD in scientific field with 2-3 years' in Quality or deep familiarity with Quality requirements through hands-on experience in pharmaceutical or biotech manufacturing Proven experience in working cross functionally, leveraging their skills to influence and drive results within the matrix organizationExceptional team player and ability to develop strong network across the company and with external partners as neededPrior people management (preferred)
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit.
As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills.
Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.
We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.
Manager, Quality Assurance Biologics Manufacturing professionals in Durham
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James DeCarlo
Permanent or contract Validation Engineer.