External Drug Product Manufacturing Lead (CDMO Oversight)

Celldex Therapeutics, Inc.; Hampton (VA); Hybrid; USD 154,000 - 200,000; Full time

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.

The role requires coordinating with clinical and commercial teams, approving invoices, reviewing batch records, and guiding investigations of excursions to prevent recurrence. Candidates should have a Bachelor’s or Master’s in Engineering or Biological Sciences, 5–8 years of experience, and travel up to 20%.

Qualifications

• Bachelor’s or Master’s degree in Engineering or Biological Sciences.
• 5-8 years’ experience managing aseptic drug filling operations at CMOs or in-house.
• Experience managing internal resources and external contractors/vendors.
• Knowledge of secondary packaging operations.
• Strong communication and organizational skills.
• Project Management Certification.
• 10-20% domestic and international travel required.

Responsibilities

• Provide oversight as person-in-plant (PIP) for Drug Product fills at CMOs.
• Lead CMOs by providing forecasts and quotations for drug product manufacturing operations.
• Liaise with clinical and commercial teams to create product forecasts.
• Investigate and onboard new Drug Product Manufacturing CMOs.
• Review invoices and batch records.
• Review excursions or deviations during shipment, handling, and storage; drive investigations to resolution with Quality, CDMO and clinical sites.

Skills

Project management

Communication

Team player

Budget analysis

Problem solving

Interpersonal skills

Process improvement

Education

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

Tools

MS Office

MS Project

Excel

PowerPoint

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.

The role requires coordinating with clinical and commercial teams, approving invoices, reviewing batch records, and guiding investigations of excursions to prevent recurrence. Candidates should have a Bachelor’s or Master’s in Engineering or Biological Sciences, 5–8 years of experience, and travel up to 20%.