Job Description

　　Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

　　Location/Division Specific Information

　　Work Location: San Francisco, CA

　　Thermo Fisher Scientific has made a significant investment in the dynamic and rapidly growing Cell Therapy space. We recently opened a 44,000-square-foot, brand-new cell therapy collaboration center on the UCSF Mission Bay campus. The facility will serve 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 UCSF and other partners. In the Cell Therapy group, we focus on providing development and clinical scale services for gene and non-gene modified cell processing for a variety of unmet medical needs.

　　How will you make an impact?

　　You will lead the Analytical Development (AD) team and will be responsible for technical research to support the development, optimization, qualification and execution of cell-based, nucleic acid-based, protein-based and chemistry-based assays that support quality control of cell therapy products under development and manufacturing. Your experience and understanding of analytical design will establish new analytical methods and standard procedures for cell therapy product characterization. You will also play a role in signing new client programs for development work. This includes working with our Commercial Operations teams by participating in the screening meetings, proposal writing and review, analytical method's evaluation, and site tours.

　　What will you do?

　　Act as lead on multiple programs and provide mentorship to other program managers

　　Investigate, design, and validate new scientific methodologies on highly critical, unique, and complex projects related to cell therapy analytical science

　　Be responsible for day-to-day AD activities and provide technical guidance to the team to develop, qualify and tech transfer assays to assess identity, purity, safety and potency of cell therapies including but not limited to FLOW cytometry, PCR/ddPCR, ELISAs, and cytotoxicity assays

　　Support the technology transfer of analytical methods to QC and assist QC with analytical method qualification and validation

　　Manage all project scopes, resource requirements, project timelines and deliverables and plan project work accordingly with departmental, functional and external collaborators

　　Work with Program Management to ensure clear expectations and successful deliverables.

　　Work with Process Development and Manufacturing groups to trouble-shoot process challenges

　　Supervise recording of results and preparation of protocols, reports, test methods, and SOPs

　　How will you get here?

　　Education

　　BS or MS in immunology, cell/molecular biology or related biological sciences

　　MS preferred; PhD is ideal

　　Equivalent combinations of education, training, and relevant work experience may be considered

　　Experience

　　6+ years’ experience related to pharmaceutical manufacturing, process, or analytical development

　　3+ years’ experience leading teams of Scientists

　　Experience working with various cell types (including T cells, NK cells, CAR-T, or Stem Cells) as well as viral or non-viral genetic modification preferred

　　Experience working in a CDMO preferred

　　Proven leadership, problem solving and critical thinking skills

　　Knowledge, Skills and Abilities

　　Advanced and deep knowledge of principles, concepts, and practices in cell therapy

　　Excellent understanding of analytical method development and characterization as it pertains to cell therapy

　　Solid understanding of GMP regulations in cGMP manufacturing

　　Excellent writing, communication, and presentation skills

　　Ability to travel (up to 10%)

　　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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one 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.

　　Compensation and Benefits

　　The salary range estimated for this position based in California is $140,000.00–$180,000.00.

　　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.