Hiring: Associate Director, AS&T Lifecycle Management (Biological Method Expert) Company: BioNTech SE Location: Gaithersburg, MD Job Posted Time: 2026-09-10 13:49:14 Employment Type: Full-time About the job Experience: •10+ years in a regulated environment in the pharmaceutical industry Required Skills: •Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory, and for late-stage and commercial projects across a global network •Lead and oversee the design and performance of method validations and transfers as well as method lifecycle activities (e.g. exchange of critical reagents, method performance and laboratory investigations); potential hands-on work in the laboratory required •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 and responses to regulatory submissions •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 •Applied hands-on capability in assay development, design and performance of method validations, as well as data analysis and statistical evaluation Qualifications: •Demonstrated ability to lead and support QC quality events and root cause investigations. •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 Compensation: •$146,300 - $234,100 / year •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!