Manager, Quality Control*
- Cambridge (Boston)
- Work experience
- Manager First Level
- Quality Management, Quality Assurance
Manager, Quality Control*
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
BioNTech US is seeking a highly motivated QC Manager (QCM) with cGMP experience to join the Technical Operations group. The manager will be responsible for supporting QC activities for peptide manufacturing and cell therapy products and work directly with contract manufacturing and testing organizations. The QCM will report to the head of Quality Control and work in close collaboration with the Manufacturing, Supply Operations, R&D and Quality Assurance groups.
Here, you’ll achieve greatness.
- Review and trending of QC testing data (release and stability)
- Review and approve method qualification and validation
- Work closely with the R&D organization to transfer novel methods to CMOs
- Author test methods, specifications, and SOPs
- Lead and author laboratory and OOS investigations
- Coordinate assignments with contract testing organizations
- Develop, manage, and report quality control metrics
- Assists with preparation of regulatory filings (INDs and IMPDs); possesses a working knowledge of a variety of guidance documents from the ICH, FDA, and other global regulatory authorities
- Manage stability activities including maintenance of stability protocols, set up of stability studies, and authoring stability reports
- Participate and contribute to department strategy, goals, and budgets
- Review and approve CoAs and vendor related documents
- Lead/author change controls related to specifications, methods, and QC related processes
- Support introduction of LIMS software
What you have to offer.
- BS or MS in Biology, Microbiology, Chemistry, or other Life Science with 5+ years of cGMP industry experience (related experience may be considered)
- Quality Control experience in cell therapy a plus
- Working knowledge of standard analytical chemistry, microbiological and/or cell therapy methods
- Experience with method validation
- Proficiency in problem solving
- Excellent communication and collaboration skills
- Ability to work within cross-functional teams
- Attention to detail and highly organized
- Experience working with cGMP contract testing labs
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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