Associate Director, AS&T Lifecycle Management (Chemical Method Expert)
BioNTech SE
July 02, 2026
On-site
Gaithersburg, MD
Operations
Your Contribution:
- Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory and for late-stage and commercial projects across a global network.
- Design and perform method validations and transfers, and lead method lifecycle activities (e.g., exchange of critical reagents, method performance and laboratory investigations); potential hands-on work required.
- Participate in strategic and technical discussions cross-functionally with CMC team members and external partners.
- Evaluate and review technical and regulatory submission documents for timely approval and market launch.
- Act as analytical SME for regulatory filings and responses to questions from health authorities.
A Good Match (Qualifications):
- Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field; 10+ years in a regulated pharmaceutical environment.
- Expertise in analytical methods specific for ADCs: drug-to-antibody ratio, free drug, residual impurities, unconjugated antibody, conjugate variants, conjugated small molecule impurities, charge variants; beneficial: HPLC, GC, mass spectrometry, NMR, IR for linker-payload intermediate.
- Hands-on assay development and method validation/transfer, including data analysis and statistical evaluation.
- Strong CMC background for late-stage development and commercial biological products.
- In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices.
- Proven experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) and interactions with health authorities.
- Experience working in intercultural, cross-functional, global teams; structured way of working.
- Highly motivated; able to work in fast-paced, fast-evolving environment.
Preferred Qualifications:
- Experience managing method validation and transfer activities across external partners.
- Ability to lead and support QC quality events and root cause investigations.
Your remuneration:
- Expected Pay Range: $146,300/year to $234,100/year + benefits, annual bonus & equity.
Application instructions:
- Contact Yushen Chang (Talent Acquisition) or jobs@biontech.de with reference to the job ID.
- Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory and for late-stage and commercial projects across a global network.
- Design and perform method validations and transfers, and lead method lifecycle activities (e.g., exchange of critical reagents, method performance and laboratory investigations); potential hands-on work required.
- Participate in strategic and technical discussions cross-functionally with CMC team members and external partners.
- Evaluate and review technical and regulatory submission documents for timely approval and market launch.
- Act as analytical SME for regulatory filings and responses to questions from health authorities.
A Good Match (Qualifications):
- Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field; 10+ years in a regulated pharmaceutical environment.
- Expertise in analytical methods specific for ADCs: drug-to-antibody ratio, free drug, residual impurities, unconjugated antibody, conjugate variants, conjugated small molecule impurities, charge variants; beneficial: HPLC, GC, mass spectrometry, NMR, IR for linker-payload intermediate.
- Hands-on assay development and method validation/transfer, including data analysis and statistical evaluation.
- Strong CMC background for late-stage development and commercial biological products.
- In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices.
- Proven experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) and interactions with health authorities.
- Experience working in intercultural, cross-functional, global teams; structured way of working.
- Highly motivated; able to work in fast-paced, fast-evolving environment.
Preferred Qualifications:
- Experience managing method validation and transfer activities across external partners.
- Ability to lead and support QC quality events and root cause investigations.
Your remuneration:
- Expected Pay Range: $146,300/year to $234,100/year + benefits, annual bonus & equity.
Application instructions:
- Contact Yushen Chang (Talent Acquisition) or jobs@biontech.de with reference to the job ID.