- Raritan, New Jersey, United States
- On-site
- Full-time · Director
- $154K–$266K per year
- 10+ years
The Director of Sterility Assurance, Cell Therapy Operations, provides site-level leadership and strategic direction for microbiological and virological control across cell therapy and lentiviral manufacturing at the Raritan facility.
Compensation
The anticipated base pay range for this position is : $154,000.00 - $265,650.00
Responsibilities
- Own the Raritan sterility assurance and contamination control program
- Develop, implement, maintain, and continuously improve the site contamination control strategy
- Provide governance and oversight for microbiological and virological control programs
- Lead site risk assessments, gap assessments, mitigation plans, and sustainable remediation activities
- Provide strategic input to facility and equipment design, process design, material and personnel flows, cleaning and disinfection, segregation controls, maintenance, environmental monitoring, and microbiological testing
Requirements
- Bachelor’s degree in microbiology, pharmacy, engineering, chemistry or a related scientific / engineering discipline
- Advanced degree (MS/PHD) preferred
- Nice to have: MS/PHD
- Nice to have: Aseptic processing in ISO 5 environments
- Nice to have: Biosafety cabinets