Director, AS&T mAb & ADC Network
About The Position
As a Scientific Leader in Analytical Sciences, you will play a pivotal role in advancing the capabilities of BioNTech's Gaithersburg antibody laboratory. Your expertise will shape analytical strategies and technology transfers, directly contributing to our mission of pioneering immunotherapies. Collaborating with cross-functional teams, you will ensure excellence in method development, validation, and lifecycle management for monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). This role offers the opportunity to influence global standards while fostering innovation within a dynamic environment.
Requirements
- Master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or related field with 12 plus 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
Nice To Haves
- PhD and knowledge of small molecule analytics.
Responsibilities
- 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
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
