Senior Associate Director, Analytical Projects & Strategy

Biopharma Careers; Gaithersburg (MD); On-site; USD 146,000 - 234,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401K with match

Paid Time Off

Tuition Reimbursement

Job summary

BioNTech in Gaithersburg, MD is seeking an Associate Director, AS&T Projects & Strategy to coordinate analytical activities across internal and external partners, ensuring alignment with development strategies and regulatory expectations.

You will lead analytical teams, drive the CMC Module 3 dossier, and collaborate with Regulatory Affairs, CMC, and Quality to support late-stage programs and potential product launches. A senior leader with deep regulatory knowledge is required.

Qualifications

• Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology or related field.
• 10+ years in a regulated pharmaceutical environment.
• Experience in analytical functions (AS&T, QA, Analytical Development) with mAbs/ADCs.

Responsibilities

• Represent the analytical function within cross-functional project teams and act as the primary interface for CMC and stakeholders.
• Coordinate analytical deliverables across internal functions and external partners.
• Shape analytical control strategy with Regulatory Affairs, CMC and Quality to meet regulatory expectations.
• Provide leadership and oversight for analytical activities and communicate progress, timelines, risks, and challenges.
• Maintain end-to-end ownership of analytical components of the CMC Module 3 dossier, including docs and lifecycle maintenance.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Project management

Stakeholder management

Communication skills

Education

Advanced degree in Biology/ Chemistry/ Pharmacy/ Biotechnology

Job description

BioNTech in Gaithersburg, MD is seeking an Associate Director, AS&T Projects & Strategy to coordinate analytical activities across internal and external partners, ensuring alignment with development strategies and regulatory expectations.

You will lead analytical teams, drive the CMC Module 3 dossier, and collaborate with Regulatory Affairs, CMC, and Quality to support late-stage programs and potential product launches. A senior leader with deep regulatory knowledge is required.