Director, Analytical Development

About the role

As Director of Analytical Development, you will play a pivotal role in advancing our antibody and ADC programs from early clinical development through BLA readiness. Your expertise will drive the technical strategy for product-specific analytical development, ensuring our methods and strategies align with BioNTech’s mission to revolutionize cancer treatment and immunotherapy.

Contribute

• Partner with global team leads to develop and implement robust method development processes and analytical control strategies
• Identify analytical risks and data gaps; design and execute mitigation studies such as comparability, forced degradation, structure-function analysis, stability testing, and investigations
• Establish internal best practices and analytical playbooks in a fast-paced environment
• Support the definition of CQAs and associated control strategies through experimental studies across various phases
• Contribute to CMC documentation (IND/IMPD, BLA/MAA) by providing technical input on analytics, product characterization, and investigations
• Lead a team of technical experts in hands-on laboratory work including method development, troubleshooting, and lifecycle management

A Good Match

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with 10+ years of relevant experience; or MS with 12+ years of industry experience
• Extensive experience in global pharma AD/AS&T for monoclonal antibodies or ADCs; late-stage clinical manufacturing/BLA readiness preferred
• Hands-on expertise in biologics method development, qualification/validation, transfer processes; knowledge of ADC-specific analytics desirable
• Strong understanding of biologics CMC guidelines (e.g., ICH Q6B), QbD principles, PPQ/BLA readiness strategies, specification setting & justification
• Proven leadership experience within dynamic cross-departmental environments; excellent communication skills to influence across matrixed teams
• Preferred requirements: Global regulatory experience (e.g., submissions or partnerships in US/EU/China)

Benefits

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance