Senior Scientist II, Analytical Development

Senior Scientist II, Analytical Development

Gaithersburg, US | full time | Job

About the Role:

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.

Your Contribution:

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

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

Prefered requirements
: 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

US based candidates expected Pay Range: $130,800 - $209,400/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).
* Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

BioNTech 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
• Sitter stream:
  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
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.

Located in the Bio Health Capital Region near Washington DC and…