Manager, Cell Therapy MSAT

Job Title: Manager, Cell Therapy MSAT

Location: San Francisco, CA

Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. Our Cell Therapy organization within the Pharma Services Group, is one of the fastest growing areas of Thermo Fisher Scientific. We focus on providing development and clinical scale services for gene and non-gene modified cell processing for a variety of unmet medical needs.

The Manager, Cell Therapy MSAT leads a team responsible for new product introductions and GMP process change management at the Princeton site, reporting to the Head of Operations, Cell Therapy.

• Provides leadership to assigned staff within the MSAT group by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
• Supports Manufacturing Ops group to ensure safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use
• Troubleshoot activities for the production processes with the objective to guarantee that the product is delivered in time, and meets quality standards
• Ensures that all tech transfers into manufacturing operations are controlled and executed within GMP regulatory guidelines.
• Provides for the identification and development of talent both within the team and across the site.
• Plans operations such that each project delivery is optimal, meeting the financial needs of the company while balancing the needs of customers and end users.
• Ensures the availability of appropriate SOPs and documentation are provided to enable right first time and on time delivery of customer tech transfer projects
• Ensure the financial performances of MSAT by monitoring and driving decisions that have positive impact on the financial results as reflected by: Revenue, cashflow, EBITA, associated allocations from others, standard costs, and production efficiencies.
• Develop and implement programs to drive operational excellence towards right first time and on-time delivery.
• Participates in strategic resource and capacity planning for the site
• Collaborate with Process Development group to ensure an appropriate process transfer with “facility fit” in mind
• Maintains good community relations with adjacent neighbors whether business, industrial, service providers, academic or households.
• Serve as an organizational change agent and foster an atmosphere of a questioning attitude, empowerment (appropriate to job level), and an error prevention/ continuous improvement mindset

Requirements

• Bachelor's degree required. MS in biological science or engineering discipline preferred.
• Equivalent combinations of education, training, and relevant work experience may be considered.
• 6 years’ experience in biopharmaceutical roles including manufacturing operations, process development and/ or MS&T in a highly regulated environment. Cell Therapy experience preferred.
• 1-3 years’ experience of leading teams and engaging customers
• Experience with biopharmaceutical drug development and clinical Manufacture. Commercial manufacture experience a plus. Experience with Cell Therapy manufacturing strongly preferred.

Knowledge, Skills, Abilities

• Ability to drive safety, quality, functional, technical and operational excellence.
• Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
• Ability to drive Customer Experience and a Commitment to Excellence.
• Ability to make timely decisions and knowing when to delegate
• Ability to work within cross functional teams and provide governance on project teams
• Effective written, interpersonal, and presentation skills.
• Ability to work on multiple projects simultaneously
• Expert knowledge of mammalian cell culture
• Leadership of people in multi-disciplinary technical and scientific teams
• Expert knowledge of regulatory guidelines: EU, US, Australian, ICH, etc.
• Leader in Operational Excellence
• Ability to travel up to 20%
• Excellent MS Office skills