
Director, AS&T mAb & ADC Network
BioNTech SE
full-time
Posted on:
Location Type: Office
Location: Gaithersburg • Maryland • United 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