Senior Biologics Tech Transfer & CPV Lead

Celldex Therapeutics, Inc.

Hampton (NJ)

On-site

USD 134,000 - 173,000

Full time

10 days ago

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Job summary

Celldex Therapeutics, Inc. is seeking a Senior Manager Biologics Manufacturing Technical Support to lead tech transfer, support manufacturing operations, and drive CPV and PV programs across internal teams and CDMOs.

You will review batch records, oversee investigations (OOS/OOT), and collaborate with manufacturing sciences, operations, analytics, and QA to ensure compliant, scalable biologics production. This role requires travel up to 30% and a strong data-driven mindset.

Qualifications

Bachelor's degree in life sciences or related field; advanced degree is a plus.
6+ years in biotech/pharma/biologics manufacturing.
3+ years with biologics CDMOs.
3+ years in late-phase biologics programs.
Strong data-driven decision-making.
Willingness to travel up to 30%.
Excellent cross-functional communication.

Responsibilities

Lead technology transfer, scale-up, risk assessment with CDMO.
Track and analyze CDMO batch data; oversee investigations and CAPAs.
Serve as PIP to monitor operations; review batch records/protocols/reports.
Lead process validation for commercialization or CPV program.
Collaborate with MSTOP, manufacturing operations, analytical and QA for tech-transfer and development.