Executive Director, Batch Release & Quality Compliance

Celldex Therapeutics, Inc.

Hampton (NJ)

On-site

USD 234,000 - 303,000

Full time

4 days ago

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Benefits offered by this job

401(k) employer contributions

Health insurance

Paid holidays

Discretionary bonus

Long-term incentive

Job summary

Celldex Therapeutics, Inc. is seeking an Executive Director, Batch Release to lead the organization’s commercial product disposition and batch release activities, ensuring compliance with global GMP regulations and quality standards.

The role will provide strategic and operational leadership for batch release across commercial and late-stage clinical programs, partnering with Technical Operations, Manufacturing, Supply Chain, Regulatory Affairs, Quality Control, and external manufacturing

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 with our CDMOs on issues related to Batch Release to ensure they are resolved in a compliant and timely manner.
Establish metrics to drive performance.