Associate Director, AS&T Lifecycle Management – Biological Method Expert

BioNTech SE

Associate Director leading product development and regulatory submission for BioNTech's therapeutic pipeline. Ensuring compliance with GMP standards and technical expertise in analytical methods.

Posted 7/3/2026full-timeGaithersburg • Maryland • 🇺🇸 United StatesSenior💰 $146,300 - $234,100 per yearWebsite

About the role

Key responsibilities & impact

Making a meaningful contribution to the ongoing product development and regulatory submission (BLA/MAA) of our Protein-based therapeutic pipeline
Be the main point of contact for specific methods within your area of expertise
Ensure that the analytical methods comply with GMP standards and provide accurate, precise, and reliable results
Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory, and for late-stage and commercial projects across a global network
Responsible for the design and performance of method validations and transfers as well as method lifecycle activities
Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners
Evaluation and review of technical and regulatory submission documents in a timely manner for the approval and market launch of development products
Act as the Analytical SME by providing expert knowledge for regulatory filings, as well as contributing expertise to questions from health authorities

Requirements

What you’ll need

An advanced university degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related field with 10+ years in a regulated environment in the pharmaceutical industry
Comprehensive expertise in chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques for the analysis of mAbs/ADCs
Hands-on experience with assay development, design and performance of method validations, as well as data analysis and statistical evaluation
Strong background in CMC activities 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 in working in intercultural, cross-functional, and global teams
Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies
Highly motivated and willingness to work in a fast-paced and fast-evolving environment

Benefits

Comp & perks

benefits
annual bonus
equity

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Chromatographic TechniquesSpectroscopic TechniquesElectrophoretic TechniquesImmunoassay TechniquesMolecular Biology TechniquesAssay DevelopmentData AnalysisStatistical EvaluationMethod ValidationMethod Lifecycle Activities

Soft Skills

Structured WorkingProblem-SolvingIntercultural TeamworkCross-Functional CollaborationMotivation