Scientist III, Cell Therapy MSAT

Work Schedule

Other

Environmental Conditions

Office

Job Description

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!

Our organization is making a significant investment in the multifaceted 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

Nurture 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 completion of program results and breakthroughs

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

Advise 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 demeanor to support tech 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 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 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

Drive safety, quality, functional, technical and operational excellence.

Ability to encourage and champion innovation, collaboration, visibility and team efficiency.

Drive Customer Experience and a dedication to Excellence.

Make timely decisions and knowing when to delegate

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 and risk assessment

Cell culture and aseptic techniques

Recognition of problems developing, not just occurring

Effective written, interpersonal, and presentation skills.

Ability to work on multiple projects simultaneously

Proficient in mammalian cell culture

Leadership of people in multi-disciplinary technical and scientific teams

Experienced knowledge of regulatory guidelines: EU, US, Australian, ICH, etc.

Leader in Operational Excellence

Ability to travel up to 20%

Ability to support weekend and/or night work as needed

Excellent MS Office skills

Compensation and Benefits

The salary range estimated for this position based in California is $90,900.00–$152,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards