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.

　　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 II, Manufacturing Sciences leads activities related to customer process transfers and serves as backup 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

　　Support 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 with other MSAT team members

　　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 mentality 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

　　Author Master Batch Records (MBRs), and review completed MBRs

　　How will you get here?

　　Education

　　Minimum Required Education: Bachelor's degree in biological science or engineering fieldExperience

　　2+ 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 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 work across departments 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 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

　　Expert knowledge of mammalian cell culture

　　Leadership of people in multi-disciplinary technical and scientific teams

　　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

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

　　Accessibility/Disability Access

　　Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

　　*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

　　Compensation and Benefits

　　The salary range estimated for this position based in California is $72,000.00–$108,000.00.

　　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

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.