Scientist Iii, Cell Therapy Msat

1 week ago

San Francisco, United States Thermo Fisher Scientific Full time

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**How will you make an impact?**

Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. Our Cell Therapy organization within the Advanced Therapy Business Unit, is one of the fastest growing areas of Thermo Fisher Scientific. We operate a 44,000-square-foot, innovative cell therapy collaboration center on the UCSF Mission Bay campus. Opened in 2023, the facility serves as a central location where customers and UCSF researchers will have access to Thermo Fisher Scientific’s broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support to our partners. In the Cell Therapy unit, we focus on providing development and clinical/commercial scale services for gene and non-gene modified cell processing for a variety of unmet medical needs.

The Scientist III, Manufacturing Sciences is the technical program lead for customer process transfers and serves as process SME, reporting to the Manager, Manufacturing Sciences.

**What will you do?**
- Demonstrate the highest example of safety and quality mindedness in all job functions
- Cultivate an atmosphere of continuous improvement, empowerment (appropriate to job level), and an error prevention
- Own technology transfer and implementation of new production processes, with the objective to produce new clinical trial products within the facility
- Participate in customer core teams as the technical operations lead for that project
- Troubleshoot activities for the production processes with the objective to guarantee that the product is delivered in time, and meets quality standards
- Optimize production processes with the objective to improve costs, speed and quality
- Implement new technology within the production facility
- Work with different functional groups to ensure timely completion of program deliverables and milestones
- Ensure timely completion of documentation packages for production scale processes, including, but not limited to:

- Applicable SOPs, Tech Transfer Master Plans, PFDs (including all disposable line builds for each program), Technology Transfer Protocols, Process Risk Assessments, and Campaign Summary reports
- Inform process development decisions with respect to facility fit and the manufacturability of development programs. Thereby, providing PD with the information required to develop fit for Suite/Site processes (i.e. raw material preferences, standard procedures, preferred operating methodologies)
- Maintain a customer and patient centric attitude to support technology transfer and batch execution
- Modify or improve procedures as required to streamline departmental processes
- Identify deviations, aid in investigations/root cause analysis/product impact assessment, and provide input on major/critical deviations
- Perform technical review of Master Batch Records (MBRs), as well as, completed MBRs

**How will you get here?**

**Education**:

- Minimum Education Required: Bachelor's degree in biological science or engineering field
- Master's degree in biological science or engineering field preferred.

**Experience**:

- 4+ years of relevant cGMP experience in a manufacturing pharmaceutical/biotech environment or related areas
- Aseptic cell culture processing in ISO 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred
- Cell therapy manufacturing experience required
- Cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation required

**Knowledge, Skills, Abilities**:

- Ability to collaborate with external customers in a professional manner, to provide updates and record actions to be shared with members of the team
- Ability to drive safety, quality, functional, technical and operational excellence.
- Ability to encourage and champion innovation, collaboration, visibility and team efficiency.
- 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
- Understanding ‘why’ and not just the ‘how’ of processes and practices
- Solid understanding of cGMP practices
- Deviation investigations, root cause analysis, and

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