BioNTech SE · 7 hours ago
Senior Scientist II, Analytical Development
Gaithersburg, MD
Full-time
Onsite
Senior Level, Lead/Staff
$131K/yr - $209K/yr
8+ years expBioNTech SE is dedicated to revolutionizing healthcare through innovative antibody and ADC products. The Senior Scientist II in Analytical Development will drive technical excellence in LC-MS method development and contribute to regulatory strategies, ensuring compliance and delivering high-quality therapies to patients worldwide.
Health Care
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
Qualification
Required
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
Preferred
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
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
Company
BioNTech SE
At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
James Ryan
Chief Legal Officer and Chief Business Officer
Recent News
2025-10-21
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