Global Batch Release & Quality Leader

Celldex Therapeutics, Inc.; Hampton, Northern (VA, KY); Hybrid; USD 234,000 - 303,000; Full time

Job summary

Celldex Therapeutics, Inc. seeks an Executive Director, Batch Release to lead commercial product disposition and batch release activities, ensuring GMP compliance and quality standards.

This role serves as the Quality representative for final disposition decisions and oversees CDMOs and related quality systems. The role provides strategic and operational leadership for batch release across commercial and late-stage programs, partnering with Technical Operations, Manufacturing, Supply Chain,

Qualifications

• Bachelor's degree in biology, microbiology, chemistry, pharmaceutical sciences, or related field; advanced degree a plus.
• 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.
• Extensive experience supporting commercial biologics, monoclonal antibodies, or complex biologic products.
• Demonstrated expertise in batch disposition and lot release responsibilities.
• Significant experience managing global CDMO and contract testing networks.
• Experience overseeing both U.S. and international manufacturing networks.
• Patient Focused
• Strategic Leadership
• Cross-Functional Stake Holder Management

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 within Celldex’s Quality, Operational and Commercial Organizations to ensure our products are released compliantly and in a timely manner for our patients.
• Work with our CDMOs on issues related to Batch Release to ensure they are resolved in a compliant and timely manner.
• Management of a growing staff to accommodate Celldex growth.
• Establish metrics to drive performance.

Skills

Quality Assurance

Batch disposition

CDMO management

GMP compliance

Leadership

Stakeholder mgmt

Biologics manufacturing

Global operations

Education

Bachelor’s degree

Advanced degree

Job description

Celldex Therapeutics, Inc. seeks an Executive Director, Batch Release to lead commercial product disposition and batch release activities, ensuring GMP compliance and quality standards.

This role serves as the Quality representative for final disposition decisions and oversees CDMOs and related quality systems. The role provides strategic and operational leadership for batch release across commercial and late-stage programs, partnering with Technical Operations, Manufacturing, Supply Chain,