Director, Quality Control*
- Cambridge, MA
- Work experience
- Research, development, teaching
Director, 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 is seeking a highly-motivated Quality Control Director with a strong cell therapy or biologics background to join BioNTech’s Technical Operations group. The candidate will manage and oversee quality control of BioNTech’s clinical supply production at contract manufacturing and testing organizations. The candidate will work in close collaboration with the Manufacturing, Supply Ops, Peptide Chemistry, Cell Therapy Unit, and Quality Assurance groups at BioNTech US and BioNTech IMfS (Germany) to support continual improvement and cGMP compliance. They will work functionally as well as part of a multi-disciplinary teams to support the development and approval of our clinical development programs.
Here, you’ll achieve greatness.
- Manage the quality control of clinical products in accordance with strict timelines and budget
- Work closely with supply operations and quality assurance to ensure cGMP compliance and meet release schedules
- Oversee cGMP laboratory investigations including QC laboratory excursions, deviations, OOS, OOT, investigations and implement CAPA, as needed.
- Set QC strategy in conjunction with the CMC team; track departmental priorities and goals, as well as QC related regulatory commitments to ensure timely and efficient delivery on key milestones
- Manage and mentor QC staff
- Participate and contribute to department strategy, goals and budgets
- Work with BioNTech’s Peptide Chemistry and Cell Therapy Unit to oversee the development, transfer and qualification of test methods to contract manufacturers
- Provide input on next generation test methods needs and requirements to improve operations and/or analytical performance.
- Provide technical and scientific guidance within QC and in collaboration with other departments.
- Author, review and approve Quality Control documentation including product specifications; protocols, SOPs, reporting of testing, validation and stability studies.
- Write and review reports and regulatory documents in support of submissions to regulatory authorities.
- Develop, manage, and report quality control metrics
- Support external auditors, as needed
What you have to offer.
- Minimum requirements; BS or MS in a Scientific Discipline with 10 plus years of industry experience and 2 plus years in supervisory/management role
- In-depth knowledge of ICH guidelines in support of cGMP operations supporting clinical manufacturing, including stability, method validation, expiry/re-test dating, and establishing specifications
- Experience in QC support of cell therapy and/or biologics manufacturing at various stages of development preferred (Preclinical, Clinical, Commercial)
- Experience with compendial safety testing (e.g. bioburden, mycoplasma, endotoxin and sterility) including rapid methodologies (e.g. BacT Alert and PCR).
- Proven track record of building and managing QC functions
- Extensive experience managing cGMP contract testing labs
- Proficiency in problem solving and leading investigations
- Strong leadership and project management skills
- Ability to work within cross-functional teams
- Strong oral and written communication skills, and collaboration skills
- Attention to detail and highly organized
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 firstname.lastname@example.org.
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!