Overview In this role you will lead Celldex's batch release program, ensuring compliant final disposition of all products across CDMOs and internal facilities. You will partner with Quality, Operations, Regulatory, and Commercial teams to release products timely while upholding global GMP standards. You will manage a growing quality organization and oversee external manufacturing networks to scale commercial and late-stage programs. This is a strategic, impact-driven leadership position focused on quality systems, supplier oversight, and patient-focused outcomes.
Compensation / Benefits- 401(k) plan with employer contribution
- health care benefits
- paid holidays
- vacation
- sick days
- annual discretionary bonus
Responsibilities- Quality and compliant release of all Celldex batches to the marketplace
- Create and execute the Batch Release Program for Celldex and CDMO-manufactured products
- Collaborate with Quality, Operational and Commercial teams to ensure compliant and timely releases
- Manage CDMO-related batch release issues to resolve them promptly and compliantly
- Lead and grow the quality organization to support Celldex growth
- Establish metrics to drive performance
Key requirements- Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering or related discipline; advanced degree is a plus
- Minimum 15 years of progressive QA experience in biotechnology/pharma/ biologics manufacturing
- Minimum 8 years of leadership experience in quality operations and commercial GMP activities
- Extensive experience with commercial biologics, monoclonal antibodies, or complex biologics
- Proven expertise in batch disposition and lot release
- Significant experience managing global CDMO and contract testing networks
- Experience overseeing both U.S. and international manufacturing networks
- Patient-focused, strategic leadership, cross-functional stakeholder management
- Patient-focused
- Strategic leadership
- Cross-functional stakeholder management
- Batch disposition and lot release
- GMP compliance and quality systems
- CDMO management and external network oversight
