Director, Analytical Development

The Director of Analytical Development will play a pivotal role in advancing BioNTech's mission to revolutionize medicine by driving analytical strategy and execution for antibody and ADC programs, ensuring readiness for regulatory milestones such as BLA submissions.

Requirements

• 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 expertise in global pharma AD/AS&T for monoclonal antibodies or ADCs; late-stage/BLA readiness experience preferred
• Proven success leading BLA readiness/PPQ activities; commercial launch experience is a plus
• Hands-on experience in biologics method development, qualification/validation, transfer processes; ADC-specific analytics knowledge desirable
• Strong understanding of biologics CMC guidelines (ICH Q6B), analytical control strategies, specification setting & justification
• Demonstrated leadership within matrixed environments; excellent communication skills
• Global submission experience across regions (e.g., US/EU/China) is advantageous
• Willingness to travel domestically/internationally based on program needs

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