Associate Director, Aseptic Drug Product Manufacturing (CMO)

Celldex Therapeutics, Inc.; Hampton (NJ); On-site; USD 154,000 - 200,000; Full time

Benefits offered by this job

401(k) plan with employer contribution

Health care benefits

Paid holidays

Vacation

Sick days

Job summary

Celldex Therapeutics, Inc. is seeking an Associate Director, External Drug Product Manufacturing to oversee aseptic filling demands at CMOs and manage budgets in line with cGMP standards.

You will lead CMO operations, forecast requirements, review batch records, investigate deviations, and collaborate with clinical and commercial teams to align production plans. Travel is anticipated to support global manufacturing activities.

Qualifications

• Bachelor’s or Master’s degree in Engineering or Biological Sciences.
• 5-8 years’ experience in managing aseptic drug filling operations at CMOs or in-house.
• Experience managing internal resources and external contractors/vendors.
• Knowledge of cGMP, regulatory compliance, and batch records/SOPs.

Responsibilities

• Provide oversight as person-in-plant (PIP) for Drug Product fills at CMOs.
• Lead CMOs by forecasting, requesting quotations for manufacturing operations.
• Liaise with clinical and commercial teams to create product forecasts.
• Investigate and onboard new Drug Product Manufacturing CMOs.

Skills

Aseptic manufacturing

Budget management

Project management

Vendor management

Batch records & SOPs

cGMP compliance

Cross-functional collaboration

Forecasting

Process improvements

Education

Bachelor’s or Master’s degree in Engineering or Biological Sciences

Tools

MS Outlook

MS Word

MS Excel

PowerPoint

MS Project

Job description

Celldex Therapeutics, Inc. is seeking an Associate Director, External Drug Product Manufacturing to oversee aseptic filling demands at CMOs and manage budgets in line with cGMP standards.

You will lead CMO operations, forecast requirements, review batch records, investigate deviations, and collaborate with clinical and commercial teams to align production plans. Travel is anticipated to support global manufacturing activities.