Biologics Drug Substance External Manufacturing Lead

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

Benefits offered by this job

Annual discretionary bonus

Long-term incentive

401(k) plan with employer contribution

Health care and other insurance

Paid holidays

Vacation

Sick days

Job summary

Celldex seeks a Manager, Biologics Drug Substance External Manufacturing to coordinate cross-functional efforts for GMP external manufacturing of biologics drug substance. You will monitor upstream/downstream operations as a PIP at the CDMO site and lead investigations on batch records and protocols.

You will also support process validation, CPV, and technology transfer while collaborating with QA, regulatory, analytical, and formulation teams to ensure compliant batch release and stability

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry or related discipline required. Advanced degree is a plus.
• 4+ years in biotech/pharma biologics manufacturing environments.
• 2+ years working with biologics CDMOs and late-phase programs.
• Excellent interpersonal and communication skills; travel is required (up to 30%).
• Proficient in MS Office tools.

Responsibilities

• Support GMP external manufacturing of clinical or commercial biologics DS.
• Serve as a person-in-plant (PIP) to monitor manufacturing batches at the CDMO site.
• Review CDMO batch records, protocols, and reports; lead troubleshooting and investigations.
• Support process validation for commercialization of biologics DS.
• Support CPV programs for commercial biologics manufacturing.
• Support technology transfer of pipeline candidates to external CDMOs.
• Collaborate with analytical, formulation, QA and regulatory teams to support batch release and stability programs.

Skills

Interpersonal skills

Willingness to travel

MS Office proficiency

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline

Advanced degree is a plus

Tools

MS Outlook

MS Word

MS Excel

MS Project

MS PowerPoint

MS Visio

Job description

Celldex seeks a Manager, Biologics Drug Substance External Manufacturing to coordinate cross-functional efforts for GMP external manufacturing of biologics drug substance. You will monitor upstream/downstream operations as a PIP at the CDMO site and lead investigations on batch records and protocols.

You will also support process validation, CPV, and technology transfer while collaborating with QA, regulatory, analytical, and formulation teams to ensure compliant batch release and stability