Manager, Biologics Drug Substance External Manufacturing

About the role

Celldex is looking for a Manager, Biologics Drug Substance External Manufacturing in Hampton, NJ. The role works cross-functionally with internal and external teams to support GMP external clinical and commercial manufacturing of biologics drug substance at a CDMO, oversees on-site operations, supports process technology transfer, process validation and continuous process verification, and follows Good Manufacturing Practices and company policies.

Key responsibilities

• Support GMP external manufacturing of clinical or commercial biologics drug substance.
• Serve as a person-in-plant (PIP) to monitor upstream and downstream batch operations at the CDMO site.
• Review CDMO batch records, protocols and reports; lead or support troubleshooting, process risk analysis and manufacturing investigations.
• Support process validation for commercialization of biologics drug substance and the CPV program for commercial biologics manufacturing.
• Support technology transfer of pipeline drug candidates to external CDMOs.
• Work with analytical, formulation, quality assurance and regulatory teams on batch release, investigations, testing and stability programs.

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology or a related discipline; advanced degree is a plus.
• 4+ years of progressive experience in biotechnology, pharmaceutical or biologics manufacturing.
• 2+ years managing or working with biologics CDMOs and 2+ years with late-phase biologics programs.
• Able to travel 30% of the time.

Required skills

• Good interpersonal skills for managing internal and external communications.
• Proficiency with MS Outlook, Word, Excel, Project, PowerPoint and Visio.

What we offer

• Expected base salary of $116,156 to $150,852.
• Annual discretionary bonus, long-term incentive, 401(k) with employer contribution, health care and other insurance for employee and family, paid holidays, vacation and sick days.