Instil Bio is seeking a driven and experienced Head of MSAT to support Clinical Manufacturing facility start-up and production activities. The Head of Clinical MSAT will build and lead a talented team responsible for technical oversight of new product introduction and manufacturing of Instil Bio’s investigational product(s) for clinical trials. The team will be responsible for technology transfers, root cause investigations, impact assessments, process improvements, and process monitoring. The successful candidate will report to the Sr. Director, Global MSAT and will be part of the Global MSAT and Site Leadership Teams. He or she will have the ability to inspire people to do their best work and be committed to continuing Instil Bio’s team spirit.
Responsibilities:
- Lead site MSAT team to support manufacturing operations including technology transfers, reviewing batch records and sample plans, authoring and reviewing planned process changes, leading process improvement initiatives
- Lead risk assessments and investigations utilizing a systematic approach and industry best practices
- Provide oversight for technology transfers, completion of gap assessments, execution of verification runs
- Build and maintain process data monitoring for clinical manufacturing
- Support regulatory filings and facility startup as needed
- Support process FMEA
- Hire and build MSAT team, mentor and develop MSAT staff by fostering an environment for personal and professional development
- Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term
- Establish strategic goals and objectives and maintain full strategic responsibility for the department
- Manage stakeholders across functions and levels within an organization; maintain communication across manufacturing network to ensure coordination and alignment
- Able to develop talent and create a working culture that is transparent and values-driven to accelerate the personal growth of employees
Requirements:
- Bachelor’s degree, in life sciences, engineering or related field. Advanced degree preferred.
- 10+ years relevant experience in the biotechnology industry
- Cell therapy experience preferred
- 3+ years managing people and teams