Biologics Manufacturing Tech Transfer & Validation Lead

Celldex Therapeutics, Inc.; Hampton (VA); On-site; USD 134,000 - 173,000; Full time

Benefits offered by this job

401(k) plan

Health care benefits

Paid holidays and vacation

Sick days

Job summary

Celldex Therapeutics, Inc. is seeking a Senior Manager Biologics Manufacturing Technical Support to lead tech transfer and provide manufacturing support across CDMOs, PV/CPV, and investigations.

You will collaborate with manufacturing sciences, operations, QA, and analytics to ensure compliant, scalable biologics production. The role requires 6+ years in biotech manufacturing, CDMO experience, and travel up to 30%.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline; advanced degree a plus.
• 6+ years of progressive experience in biotechnology/pharmaceutical/biologics manufacturing.
• 3+ years with biologics CDMOs and late-stage biologics programs.
• Strong data-driven decision making and cross-functional communication.
• Ability to travel ~30% of the time.

Responsibilities

• Lead technology transfer, scale-up, risk assessment, and CDMO coordination.
• Oversee CDMO batch data and manufacturing investigations (OOS/OOT) with CAPA.
• Act as person-in-plant to monitor upstream/downstream operations and review records.
• Lead process validation and CPV programs for commercial biologics.
• Collaborate with MSTE, QA, analytics, and operations to support tech-transfer and development.

Skills

CDMO management

Late-stage biologics

Data-driven decisions

Interpersonal skills

Travel 30%

JMP/Minitab

MS Office/Visio

Biotech manufacturing

Education

Bachelor's degree or higher

Tools

JMP/Minitab

MS Office

Visio

Job description

Celldex Therapeutics, Inc. is seeking a Senior Manager Biologics Manufacturing Technical Support to lead tech transfer and provide manufacturing support across CDMOs, PV/CPV, and investigations.

You will collaborate with manufacturing sciences, operations, QA, and analytics to ensure compliant, scalable biologics production. The role requires 6+ years in biotech manufacturing, CDMO experience, and travel up to 30%.