Biologics Drug Substance External Manufacturing Lead

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

Job summary

Celldex Therapeutics, Inc. in Virginia is seeking a Manager, Biologics Drug Substance External Manufacturing.

You will work cross-functionally with internal and external teams to support GMP external manufacturing of clinical and commercial biologics DS at the CDMO site. Key responsibilities include monitoring batches, reviewing CDMO records, supporting process validation and CPV, and facilitating technology transfer.

Qualifications

• 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.

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 flexibility

Education

Bachelor's degree in Life Sciences or related discipline

Tools

MS Outlook

MS Word

MS Excel

MS Project

MS PowerPoint

Visio

Job description

Celldex Therapeutics, Inc. in Virginia is seeking a Manager, Biologics Drug Substance External Manufacturing.

You will work cross-functionally with internal and external teams to support GMP external manufacturing of clinical and commercial biologics DS at the CDMO site. Key responsibilities include monitoring batches, reviewing CDMO records, supporting process validation and CPV, and facilitating technology transfer.