Associate Director, AS&T Lifecycle Management (Biological Method Expert)
BioNTech SE
July 02, 2026
On-site
Gaithersburg, MD
Operations
Responsibilities:
- Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory and late-stage/commercial projects across a global network.
- Design and perform method validations and transfers; manage method lifecycle activities (e.g., exchange of critical reagents, method performance, and laboratory investigations); potential hands-on laboratory work required.
- Participate in strategic and technical cross-functional discussions with CMC team members and external partners.
- Evaluate and review technical and regulatory submission documents for approval and market launch of development products.
- Serve as Analytical SME for regulatory filings; support responses to health authority questions and regulatory submission questions.
Qualifications (Required):
- Advanced university degree (Biology, Chemistry, Pharmacy, Biotechnology, or related) and 10+ years in a regulated pharmaceutical environment.
- Expertise in chromatographic, spectroscopic, electrophoretic, immunoassay, and molecular biology techniques for analysis of mAbs/ADCs.
- Hands-on experience with assay development, method validation (design and performance), and data/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 regulatory filing experience for biologicals (IND/IMPD, BLA/MAA) and interactions with health authorities.
- Experience working in intercultural, cross-functional, global teams.
- Structured working style; ability to break down complex challenges and plan timelines/interdependencies.
- Highly motivated; able to work in a fast-paced, evolving environment.
Preferred Qualifications:
- Experience managing method validation and transfer activities across external partners.
- Demonstrated ability to lead/support QC quality events and root cause investigations.
Benefits:
- Expected pay range: $146,300/year to $234,100/year + benefits, annual bonus & equity (variable).
Application Instructions:
- Contact Yushen Chang (Talent Acquisition) or jobs@biontech.de with reference to Job ID 11546.
- Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory and late-stage/commercial projects across a global network.
- Design and perform method validations and transfers; manage method lifecycle activities (e.g., exchange of critical reagents, method performance, and laboratory investigations); potential hands-on laboratory work required.
- Participate in strategic and technical cross-functional discussions with CMC team members and external partners.
- Evaluate and review technical and regulatory submission documents for approval and market launch of development products.
- Serve as Analytical SME for regulatory filings; support responses to health authority questions and regulatory submission questions.
Qualifications (Required):
- Advanced university degree (Biology, Chemistry, Pharmacy, Biotechnology, or related) and 10+ years in a regulated pharmaceutical environment.
- Expertise in chromatographic, spectroscopic, electrophoretic, immunoassay, and molecular biology techniques for analysis of mAbs/ADCs.
- Hands-on experience with assay development, method validation (design and performance), and data/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 regulatory filing experience for biologicals (IND/IMPD, BLA/MAA) and interactions with health authorities.
- Experience working in intercultural, cross-functional, global teams.
- Structured working style; ability to break down complex challenges and plan timelines/interdependencies.
- Highly motivated; able to work in a fast-paced, evolving environment.
Preferred Qualifications:
- Experience managing method validation and transfer activities across external partners.
- Demonstrated ability to lead/support QC quality events and root cause investigations.
Benefits:
- Expected pay range: $146,300/year to $234,100/year + benefits, annual bonus & equity (variable).
Application Instructions:
- Contact Yushen Chang (Talent Acquisition) or jobs@biontech.de with reference to Job ID 11546.