Biologics Drug Substance External Manufacturing Lead

Celldex Therapeutics, Inc.; Hampton (NJ); On-site; USD 116,000 - 151,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking a Manager, Biologics Drug Substance External Manufacturing to coordinate cross-functional efforts for GMP external manufacturing of biologics drug substance (DS).

The role oversees on-site activities at the CDMO, supports technology transfer, PV and CPV, and ensures compliance with company policies. The position requires a Bachelor's degree in Life Sciences or related field, 4+ years in biotech/pharma manufacturing, and 2+ years working with biologics CDMOs.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline.
• 4+ years of progressive experience within biotechnology, pharmaceutical, or biologics manufacturing environments.
• 2+ years of experience in managing or working with biologics CDMOs.
• 2+ years of experience in working with late-phase biologics programs
• Interpersonal skills to effectively manage internal and external communications.
• Able to travel 30 % of time.
• Proficient in MS Outlook, Word, Excel, Project, PowerPoint, Visio.

Responsibilities

• Support GMP external manufacturing of clinical or commercial biologics DS.
• Serve as a person-in-plant (PIP) to monitor manufacturing batches (upstream/downstream processing) operations at the CDMO site.
• Review CDMO batch records, protocols, and reports. Lead/ support troubleshooting, process risk analysis and manufacturing investigations.
• Support process validation for commercialization of biologics drug substance.
• Support Continuous Process Verification (CPV) program for commercial biologics manufacturing.
• Support technology transfer of pipeline drug candidates to external CDMOs.
• Collaborate closely with internal and external cross-functional teams like analytical, formulation, quality assurance and regulatory to support batch release, manufacturing investigations, testing and stability programs.

Skills

Interpersonal skills

Travel readiness

Communication

Education

Bachelor's degree

Advanced degree a plus

Tools

MS Outlook

MS Word

MS Excel

MS Project

MS PowerPoint

MS Visio

Job description

Celldex Therapeutics, Inc. is seeking a Manager, Biologics Drug Substance External Manufacturing to coordinate cross-functional efforts for GMP external manufacturing of biologics drug substance (DS).

The role oversees on-site activities at the CDMO, supports technology transfer, PV and CPV, and ensures compliance with company policies. The position requires a Bachelor's degree in Life Sciences or related field, 4+ years in biotech/pharma manufacturing, and 2+ years working with biologics CDMOs.