The Sr. Manager Manufacturing Sciences will support tech transfer and cGMP clinical operations at our San Francisco, CA Cell Therapy site.
How will you make an impact?
The Senior Manager Manufacturing Sciences leads all manufacturing operations including manufacturing support services and all site GMP manufacturing. Will lead Operations, MSAT and Engineering functions reporting to the GM of Cell Therapy.
What will you do?
- Provides leadership to assigned staff 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.
- Ensures safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use
- Ensures that all production 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 timely GMP batch record release
- Ensure the financial performances of operations 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.
- Maintains good community relations with adjacent neighbors whether business, industrial, service providers, academic or households.
How will you get here?
- MS in biological science or engineering discipline
- Equivalent combinations of education, training, and relevant work experience may be considered.
- 10 years’ experience of managing biomanufacturing/cell therapy operations in a highly regulated environment.
- 10 years’ experience of operating multi-product facilities to produce clinical and commercial APIs
- 5-10 years’ experience of leading teams and engaging customers
- Experience of biopharmaceutical drug development (>15 products), clinical and commercial manufacture of Biologics API (>10 products)
Knowledge, Skills, Abilities
- Ability to drive safety, quality, functional, technical and operational excellence.
- Ability to inspire and foster innovation, collaboration, tranparency 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 manage multiple 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 products
- Expert knowledge in biopharmaceutical development
- 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 10%
- Excellent MS Office skills