Overview:
The Executive Director, Batch Release to lead the organization's commercial product disposition and batch release activities while ensuring compliance with global GMP regulations and quality standards. This leadership role will serve as the Quality representative responsible for final product disposition decisions, oversight of contract manufacturing organizations (CDMOs), and execution of quality systems supporting commercial manufacturing operations.
The Executive Director will provide strategic and operational leadership for batch release across commercial and late-stage clinical programs, partnering closely with Technical Operations, Manufacturing, Supply Chain, Regulatory Affairs, Quality Control, and external manufacturing partners. The successful candidate will bring deep expertise in commercial biologics manufacturing, GMP compliance, quality systems, and external network 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.
- Working 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.
Qualifications:
- Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline. Advanced degree is 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
Compensation Statement:
The expected base salary for this position is: $233631.00 to $303417.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.