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Director, AS&T mAb & ADC Network

BioNTech SE
4 months ago
On-site
Gaithersburg, MD
Clinical Research and Development
Your Contribution:
- 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
- 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

A Good Match:
- Master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or related field with 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 and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
- Proficiency in project management within cross-functional CMC teams and external stakeholder environments
- Exceptional communication skills

Preferred qualifications:
- PhD and knowledge of small molecule analytics.

Your Benefits (explicitly stated):
- Medical, Dental and Vision; Life/AD&D/Critical Illness; HSA/FSA; EAP 24/7; Parental/Childbirth leave; Paid Time Off; 401(K) with company match; Tuition reimbursement; Professional development; Commuting allowance and subsidized parking; Discounted Home/Auto/Pet Insurance.

Apply now:
- Apply for the Gaithersburg, US location and submit your documents using the online form.