BioNTech SE

Director, AS&T mAb & ADC Network

BioNTech SE

full-time

Posted on:

Location Type: Office

Location: GaithersburgMarylandUnited States

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Salary

💰 $168,100 - $268,700 per year

Job Level

About the role

  • Provide scientific and strategic leadership for analytical activities in the Gaithersburg antibody laboratory
  • Drive technology transfers for mAb and ADC programs, leveraging expertise in chromatography, CE, and bioassays
  • Coach and develop team members on analytical aspects of antibodies and ADCs to enhance technical expertise
  • Review regulatory-compliant project documentation, including development reports and validation protocols
  • Own and lead analytical work packages within global technical operations independently
  • Participate in technical visits with collaboration partners, CDMOs, or vendors
  • Offer subject matter expertise during internal audits and Health Authority inspections
  • Define and continuously improve global standards for analytical transfer, method validation, and lifecycle management
  • Represent Analytical Sciences in senior-level interactions with CMOs/CTOs to shape partner strategy and network readiness

Requirements

  • Master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or related field
  • 12+ years in mAb and ADC analytical technologies
  • Strong background in late-stage commercial projects with strategic execution across drug development stages
  • Solid GMP knowledge paired with experience in regulatory filings for biologicals (IND/IMPD, BLA/MAA)
  • Proficiency in project management within cross-functional CMC teams and external stakeholder environments
  • Exceptional communication skills to convey complex technical matters clearly to diverse audiences
  • Preferred qualifications: PhD and knowledge of small molecule analytics.
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
chromatographyCEbioassaysanalytical technologiesmethod validationlifecycle managementproject managementGMP knowledgeregulatory filingssmall molecule analytics
Soft Skills
scientific leadershipstrategic executioncoachingcommunication skillsteam developmentcollaborationsubject matter expertiseproblem-solvinginterpersonal skillsstakeholder management
Certifications
Master’s degreePhD