Director, Analytical Development

Director, Analytical DevelopmentGaithersburg, US | full time | Job ID: 11211About the Role: 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.Your Contribution:Collaborate with SMEs and GTD leads to develop robust methods, analytical control strategies, and seamless transfer packagesProactively 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 playbooksDefine CQAs and evolve associated control strategies across development phases aligned with ICH Q6B guidelinesLead or contribute significantly to CMC documentation (IND/IMPDs, BLAs/MAAs) and technical responses related to analyticsEngage in hands-on laboratory work including method development, troubleshooting, and oversight of testing activitiesA 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 experienceExtensive expertise in global pharma AD/AS&T for monoclonal antibodies or ADCs; late-stage/BLA readiness experience preferredProven success leading BLA readiness/PPQ activities; commercial launch experience is a plusHands-on experience in biologics method development, qualification/validation, transfer processes; ADC-specific analytics knowledge desirableStrong understanding of biologics CMC guidelines (ICH Q6B), analytical control strategies, specification setting & justificationDemonstrated leadership within matrixed environments; excellent communication skillsGlobal submission experience across regions (e.g., US/EU/China) is advantageousWillingness to travel domestically/internationally based on program needsYour BenefitsBioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: 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 and more! More details to be shared.