COVID-19 Related Update:
Interviews will be conducted via video calls:
Candidates will conduct interviews online.
Potential for new employees starting remotely:
If hired, employees will initially receive training remotely and may be able to temporarily start working remotely from home for select roles, until the COVID-19 situation is resolved.
- Bachelor of Science in biological sciences or other relevant field of study. Advanced degree preferred.
- Minimum of 15 years of relevant experience of which at least 5-10 years in a Management role overseeing a laboratory environment with applicable clinical or commercial experience. Experience with environmental monitoring and aseptic processing is preferred.
- Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
- Understanding of quality system applications, including the training, deviations, CAPA management, etc.
- Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
- Experience in organizing and leading teams.
- Experience participating in health authority inspections and/or client audits.
- Understand requirements pertaining to aseptic manufacture of cellular products.
- Strong understanding of Tech Transfer and Method Validation
- Ability to work effectively with clients in a contract manufacturing environment.
- Familiarity with the product development process for biological products is helpful.
- Ability to recruit, lead and develop a high-performance manufacturing organization.
- Capable to communicate in English
- Strong written and oral communication skills
Minimum Required Training (optional)
- Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.
- Must be able to foster and work in a team-oriented environment.
- Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary.
- May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
- Small breakroom available. No on-site cafeteria available.
- The job requires communication with the site leadership during and after working hours as well as working with challenging clients, contractors and advisory personnel.