Associate Director, Drug Substance — GMP Biologics

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

Job summary

Celldex Therapeutics, Inc. is seeking an Associate Director CMC Drug Substance to drive cross-functional efforts for DS GMP external manufacturing, tech transfer, PV/CPV, and CTD Module 3 preparation for commercialization of pipeline candidates.

You will interact with analytical, formulation, QA, and regulatory teams to ensure batch release and regulatory readiness. The role requires a Master’s degree in a related field, 8+ years in biotech/manufacturing, and 2+ years leading CDMO

Qualifications

• Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Biological Sciences, or a related field.
• 8+ years of experience in biotechnology, pharmaceutical, or biologics manufacturing.
• 3+ years of experience with biologics CDMOs.
• 2+ years of experience with late-phase biologics programs and CMC writing.

Responsibilities

• Support process characterization and validation for commercialization of pipeline drug candidates.
• Support GMP external manufacturing of clinical or commercial biologics DS.
• Review CDMO batch records, protocols, and reports; lead troubleshooting and investigations.

Skills

Interpersonal skills

Ability to travel

Education

Master’s degree in Chemical Engineering/ Biochemical Engineering/ Biochemistry/ Biological Sciences

Tools

MS Outlook

MS Word

MS Excel

MS Project

MS PowerPoint

MS Visio

Job description

Celldex Therapeutics, Inc. is seeking an Associate Director CMC Drug Substance to drive cross-functional efforts for DS GMP external manufacturing, tech transfer, PV/CPV, and CTD Module 3 preparation for commercialization of pipeline candidates.

You will interact with analytical, formulation, QA, and regulatory teams to ensure batch release and regulatory readiness. The role requires a Master’s degree in a related field, 8+ years in biotech/manufacturing, and 2+ years leading CDMO