Senior Biologics Manufacturing Tech Transfer Lead

Celldex; Hampton (NJ); On-site; USD 134,000 - 173,000; Full time

Benefits offered by this job

401K plan

Health care

Paid holidays

Vacation and sick days

Long term incentive

Job summary

The Senior Manager Biologics Manufacturing Technical Support at Celldex leads cross-functional tech transfer, supports manufacturing, and oversees CDMO deviations and investigations, PV and CPV, while ensuring GMP compliance.

Partnering with manufacturing sciences, operations, analytics and QA, you will review batch records, lead scale-up, risk assessments, and CPV/PV activities in collaboration with internal teams and external CDMOs; travel up to 30% is required.

Qualifications

• The candidate will have 6+ years in biotech/pharma manufacturing environments.
• Experience with biologics CDMOs a plus and late-phase programs.
• Strong data-driven decision making and cross-functional communication.

Responsibilities

• Lead technology transfer, scale-up, risk assessment, facility and process fit with CDMO.
• Track and analyze CDMO batch data; oversee investigations (OOS/OOT) and CAPA.
• Serve as person-in-plant to monitor upstream/downstream ops; review batch records, protocols, and reports.
• Lead process validation for commercialization or CPV programs for biologics.

Skills

Tech transfer leadership

Scale-up expertise

Risk assessment

Cross-functional collaboration

Data-driven decision making

Process validation

CPV program

Travel readiness

Education

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

Advanced degree is a plus

Tools

JMP

Minitab

MS Office

Visio

Job description

The Senior Manager Biologics Manufacturing Technical Support at Celldex leads cross-functional tech transfer, supports manufacturing, and oversees CDMO deviations and investigations, PV and CPV, while ensuring GMP compliance.

Partnering with manufacturing sciences, operations, analytics and QA, you will review batch records, lead scale-up, risk assessments, and CPV/PV activities in collaboration with internal teams and external CDMOs; travel up to 30% is required.