Manager, Analytical Development

BioNTech•Gaithersburg, MD
•$113,600 - $181,600•Onsite

About The Position

As Manager, Analytical Development, you will play a pivotal role in advancing BioNTech’s mission by leading a dedicated team focused on supporting antibodies and ADC products. In this hands-on role, you will provide technical leadership for method development, optimization, comparability, and transfer readiness while contributing to analytical/CMC strategy teams. You will work closely with cross-functional teams to translate analytical findings into actionable insights that drive program success. This is an exciting opportunity to combine your management expertise and technical skills in a lab-based environment to make a meaningful impact on biologics programs.

Requirements

  • PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related discipline with 6 plus years’ relevant experience (including post-doctoral training), or MS with 8 plus years of directly relevant industry experience
  • 6–10 years of experience in analytical development/sciences within biopharmaceuticals; late-stage/BLA experience strongly preferred
  • At least 1 year of management experience in the biopharmaceutical industry
  • Expertise in developing physiochemical methods such as HPLC, icIEF, CE-SDS, DAR-related methods or extended characterization techniques
  • Solid understanding of biologics CMC expectations including analytical control strategy and late-stage development considerations; BLA-enabling extended characterization experience is a plus
  • Strong technical writing skills paired with exceptional data analysis and problem-solving abilities
  • Effective collaboration skills within cross-functional teams in dynamic environments
  • Willingness to travel domestically and internationally as needed

Responsibilities

  • Lead and mentor a team of Associate Scientists to ensure timely execution of routine testing
  • Perform hands-on laboratory activities for method development, optimization, troubleshooting, and phase-appropriate assay support for biologics such as antibodies and ADCs
  • Generate, analyze, interpret, and document high-quality data packages to support product/process development, comparability studies, method transfers, and late-stage program needs
  • Support analytical method lifecycle activities including qualification/validation readiness and transfer support
  • Prepare technical documentation such as protocols, reports, study summaries, and CMC-related documents
  • Collaborate cross-functionally with internal teams and external partners to improve workflows and best practices

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

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What This Job Offers

Job Type

Full-time

Career Level

Manager

Education Level

Ph.D. or professional degree

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