Senior Manager, Biologics Manufacturing Technical Support

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

Overview

The Senior Manager Biologics Manufacturing Technical Support works cross-functionally with internal and external teams to lead technology transfer, provide manufacturing technical support, manage Contract Development Manufacturing Organization (CDMO) manufacturing deviations and investigations, process validation (PV), and continuous process verification (CPV) while adhering to Good Manufacturing Practices, company policies and procedures.

Responsibilities

• Lead technology transfer, scale-up, risk assessment, facility and process fit in partnership with CDMO.

• Track and analyze CDMO batch data using statistical tools, provide oversight as a technical expert for manufacturing investigations (OOS/OOT) and implementation of corrective actions.

• Serve as a person-in-plant (PIP) when required to monitor manufacturing (upstream/downstream processing) operations. Review manufacturing batch records, protocols, and reports.

• Lead process validation for commercialization of biologics drug substance or continuous Process Verification (CPV) program for commercial biologics manufacturing.

• Collaborate closely with internal and external cross-functional teams like manufacturing sciences and technology, manufacturing operations, analytical and quality assurance to support tech-transfer, scale-up, manufacturing investigations, process validation, and technology development.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline. Advanced degree is a plus.

• 6+ years of progressive experience within biotechnology, pharmaceutical, or biologics manufacturing environments.

• 3+ years of experience in managing or working with biologics CDMOs.

• 3+ years of experience in working with late-phase biologics programs

• Interpersonal skills to effectively manage internal and external communications.

• Strong scientific data-driven decision-making skills.