Associate Director, Drug Substance | CMC & Tech Transfer

Celldex Therapeutics, Inc.; Hampton (VA); On-site; USD 154,000 - 200,000; Full time

Job summary

Celldex Therapeutics, Inc. seeks an Associate Director CMC Drug Substance to drive process characterization and transfer for pipeline candidates. The role collaborates across analytical, formulation, QA, and regulatory teams to ensure robust manufacturing for clinical and commercial programs.

You will manage external CDMOs, oversee batch records, and author CTD Module 3 documentation, while enabling CPV programs and continuous improvements in manufacturing.

Qualifications

• Master's degree in a relevant field.
• 8+ years of progressive experience in biotechnology, pharmaceutical, or biologics manufacturing.
• 3+ years of experience with biologics CDMOs.
• 2+ years of experience in working with late-phase biologics programs.
• 2+ years of experience in authoring CMC technical writing.
• Ability to travel 10-15% of time.
• Strong interpersonal and cross-functional collaboration skills.

Responsibilities

• Support process characterization and validation for commercialization of pipeline drug candidates.
• Lead/ support GMP external manufacturing of clinical or commercial biologics DS.
• Review CDMO batch records, protocols, and reports; lead troubleshooting and investigations.
• Serve as a person-in-plant (PIP) to assist in CDMO activity management.
• Lead technology transfer of pipeline drug candidates to external CDMOs.
• Support authoring Module 3 of the DS CTD for regulatory submissions.
• Support CPV program for commercial biologics manufacturing.
• Collaborate with analytical, formulation, quality assurance and regulatory teams for batch release and stability programs.

Skills

Biologics

Project management

Cross-functional communication

Regulatory writing

Education

Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Biological Sciences or science related field

Tools

MS Office Suite (Outlook, Word, Excel, Project, Visio)

Job description

Celldex Therapeutics, Inc. seeks an Associate Director CMC Drug Substance to drive process characterization and transfer for pipeline candidates. The role collaborates across analytical, formulation, QA, and regulatory teams to ensure robust manufacturing for clinical and commercial programs.

You will manage external CDMOs, oversee batch records, and author CTD Module 3 documentation, while enabling CPV programs and continuous improvements in manufacturing.