Senior Scientist II, Analytical Development

BioNTech•Gaithersburg, MD

About The Position

As a Senior Scientist II, Analytical Development, you will play a pivotal role in advancing BioNTech's mission to revolutionize healthcare through innovative antibody and ADC products. You will be part of a dynamic, lab-based team, driving technical excellence in LC-MS method development and characterization while contributing to regulatory strategies and submissions. Your expertise will directly support our goal of delivering high-quality therapies to patients worldwide. In this role, you will thrive in a fast-paced environment where ambiguity is an opportunity. Your ability to distill complex data into actionable insights will be instrumental in shaping analytical strategies and ensuring compliance with regulatory standards. Join us and make a meaningful impact on cutting-edge biopharmaceutical development.

Requirements

PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with relevant post-doctoral and 8 plus years industry experience; alternatively MS with substantial industry experience
Hands-on expertise in LC-MS method development, qualification/validation, transfer processes; global experience (e.g China and/or global partners) is advantageous
Strong background in biologics CMC principles including ICH Q6b standards, PPQ/BLA readiness, analytical control strategies, and specification setting
Experience developing characterization methods for antibodies (e.g., glycans analysis) using diverse ionization modes preferred
Proven track record as a technical leader within cross-functional teams in dynamic environments
Open-minded approach to ambiguity; ability to create structured solutions where none exist

Nice To Haves

7 plus years in global pharma AD and/or AS&T for monoclonal antibodies or related biologics; late-stage / BLA experience.
Hands-on expertise in LC-MS method development, qualification/validation, transfer processes; global experience (e.g China and/or global partners) is advantageous

Responsibilities

Develop and execute phase-appropriate LC-MS strategies across early and late development stages, including BLA-enabling activities
Identify analytical risks and gaps; design mitigation plans and study strategies such as comparability, stability, characterization, and investigations
Mentor scientists in LC-MS fundamentals, fostering scientific rigor and continuous improvement within the team
Define and refine internal workflows and best practices for analytical development in high-impact environments
Lead optimization and qualification of LC-MS assays across platforms (e.g., intact mass, peptide mapping, released glycan analysis)
Implement Multi-Attribute Methods (MAM) for antibody characterization, QC support, comparability studies, and change control

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