Associate Director, Projects & Strategy, Analytics, Science & Technology (AS&T)
$146,300–$234,100 year
On-siteGaithersburg, Maryland, United States
Job Summary
Associate Director, AS&T Projects & Strategy at BioNTech US (Gaithersburg, MD) leads coordination of analytical activities across internal and external partners, representing the analytical function within cross-functional late-stage CMC teams and driving development programs toward commercialization. Responsibilities include coordinating deliverables across analytical functions and external partners, shaping the analytical control strategy with Regulatory Affairs, CMC, and Quality, and providing leadership with transparent communication on progress, timelines, risks, and dependencies. Maintains end-to-end ownership of analytical components for the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance. Requires an advanced scientific degree and 10+ years of regulated pharma experience, with deep knowledge of mAbs/ADCs, regulatory expectations, and strong cross-functional collaboration.
Required Qualifications
- Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related scientific discipline
- 10+ years of experience in a regulated pharmaceutical environment
- Broad experience within analytical functions (AS&T, Quality Control, Analytical Development)
- Experience with monoclonal antibodies (mAbs), multi-specific antibodies, and/or antibody-drug conjugates (ADCs)
- Demonstrated leadership capabilities and project-management experience
- Strong understanding of US and EU regulatory frameworks (FDA, EMA, GMP, CMC)
- Knowledge of regulatory documentation and lifecycle management (e.g., dossier preparation)
- Excellent communication and stakeholder-management skills
- Ability to work in intercultural, cross-functional, and global teams
- Experience supporting pre-approval activities (e.g., PLI readiness, BLA preparation) is advantageous
Desired Qualifications
- Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related scientific discipline
- 10+ years of experience in a regulated pharmaceutical environment
- Broad experience within analytical functions (AS&T, Quality Control, Analytical Development)
- Experience with monoclonal antibodies (mAbs), multi-specific antibodies, and/or antibody-drug conjugates (ADCs)
- Demonstrated leadership capabilities and project-management experience
- Strong understanding of US and EU regulatory frameworks (FDA, EMA, GMP, CMC)
- Knowledge of regulatory documentation and lifecycle management (e.g., dossier preparation)
- Excellent communication and stakeholder-management skills
- Ability to work in intercultural, cross-functional, and global teams
- Experience supporting pre-approval activities (e.g., PLI readiness, BLA preparation) is advantageous
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