Jobs at Celldex

The Manager, Biologics Drug Substance External Manufacturing works cross-functionally with internal and external teams to support drug substance (DS) GMP external clinical and commercial manufacturing, oversee operations on-site at the Contract Development Manufacturing Organization (CDMO), support process technology transfer, process validation (PV), and continuous process verification (CPV) while adhering to Good Manufacturing Practices, company policies and procedures.

• 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 Contract Development and Manufacturing Organization (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.

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline. Advanced degree is a plus.
• 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 the use MS Outlook, Word, Excel, Project, PowerPoint, Visio.