By creating next-generation therapies for defeating cancer and disease, this company is making waves in the biotech space. With current expansion plans, it's a really exciting time to join the team!
Responsibilities:
- Work as the primary point of management for Cell Therapy Manufacturing Operations
- Provide cross-functional leadership across Quality, Engineering, Validation, Maintenance and Supply Chain
- Actively support facility design, equipment qualification and start-up operations in a cGMP compliant environment
- Provide operations strategy to meet company goals requirements
- Review & approve validation documents in support of manufacturing processes
- Ensure deviations, CAPA, change controls, process transfers and other business systems are supported/driven to completion
- Hire & train individual contributors, providing ongoing coaching/discipline
- Lead annual performance reviews
- Facilitate technology transfers from Process Development or other manufacturing sites
- Perform other duties as assigned
Requirements:
- Bachelor's Degree in Chemical Engineering, Genetics, Molecular Biology, Microbiology, Biochemistry or related field
- 10+ years of relevant industry experience (or Master's of Science with 8+ years)
- 7+ years of experience in a management role
- Proven track record of managing a cGMP production unit
- Extensive experience managing upstream/cell therapy operations
- Experience in aseptic processing and cGMP manufacturing (biologics a plus)
- Continuous Improvement background
- Knowledge of cell culture/cell physiology