Global Head, Batch Release & Quality – Biologics

Celldex; Hampton (NJ); On-site; USD 234,000 - 303,000; Full time

Job summary

Celldex in New Jersey seeks an Executive Director, Batch Release to lead commercial product disposition and final batch release, ensuring global GMP compliance and quality standards. This role acts as the Quality representative for disposition decisions and oversees CDMOs and quality systems supporting commercial manufacturing.

The successful candidate will provide strategic and operational leadership for batch release across commercial and late-stage programs, partnering with Technical

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline.
• Minimum 15 years of progressive experience in Quality Assurance within biotechnology, pharmaceutical, or biologics manufacturing environments.
• Minimum 8 years of leadership experience managing quality operations and commercial GMP activities.

Responsibilities

• Responsible for the Quality and Compliant Release of all Celldex batches to the marketplace.
• Responsible for the creation and execution of the Batch Release Program for Celldex and the products manufactured at our CDMOs.
• Work collaboratively with Celldex’s Quality, Operational and Commercial Organizations to ensure compliant and timely release for patients.
• Work with CDMOs on Batch Release issues to resolve them in a compliant, timely manner.

Skills

Quality Assurance leadership

Batch disposition

GMP compliance

CDMO management

Education

Bachelor's degree in Biology/related

Advanced degree is a plus

Job description

Celldex in New Jersey seeks an Executive Director, Batch Release to lead commercial product disposition and final batch release, ensuring global GMP compliance and quality standards. This role acts as the Quality representative for disposition decisions and oversees CDMOs and quality systems supporting commercial manufacturing.

The successful candidate will provide strategic and operational leadership for batch release across commercial and late-stage programs, partnering with Technical