Director, Analytical Development

BioNTech•Gaithersburg, MD

23h

About The Position

As Director of Analytical Development, you will play a pivotal role in advancing BioNTech’s mission to revolutionize medicine. Your work will drive analytical strategy and execution for antibody and ADC programs, ensuring readiness for regulatory milestones such as BLA submissions. Partnering with cross-functional teams in Process Development, Global Technical Development, AS&T, Regulatory, and Quality, you will operate primarily in non-GMP laboratories to deliver impactful solutions that shape the future of biologics development. This role offers an opportunity to lead innovative analytical strategies in a dynamic environment where your contributions will directly influence global regulatory submissions and product commercialization.

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

Responsibilities

Collaborate with SMEs and GTD leads to develop robust methods, analytical control strategies, and seamless transfer packages
Proactively identify analytical risks and data gaps; design and implement risk mitigation studies (e.g., characterization, comparability, stability)
Establish internal best practices for phase-appropriate CMC hand-offs and analytical playbooks
Define CQAs and evolve associated control strategies across development phases aligned with ICH Q6B guidelines
Lead or contribute significantly to CMC documentation (IND/IMPDs, BLAs/MAAs) and technical responses related to analytics
Engage in hands-on laboratory work including method development, troubleshooting, and oversight of testing activities

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