Overview Scientist II, Analytical Development Cell Therapy Join to apply for the Scientist II, Analytical Development Cell Therapy role at Thermo Fisher Scientific. Our Advanced Cell Therapy group operates in a cGMP manufacturing facility on the UCSF Mission Bay campus in San Francisco, providing pre-clinical development and clinical manufacturing services for cell therapies for unmet medical needs. How will you make an impact? As a member of the Analytical Development (AD) team, apply technical skills to conduct experiments to support clients\' cell therapy needs. Your experience in assay design and development to establish new analytical methods for cell therapy product characterization will be applied for collaborative planning, implementing, and troubleshooting experiments. Responsibilities Develop and optimize analytical methods including cell-based assays, flow cytometry, qPCR, ddPCR, ELISA, Luminex, cell viability, and other relevant techniques. Perform development, pre-qualification, and assist with validation studies to evaluate fit-for-use of analytical methods as per current regulatory guidelines. Analyze experimental data and draw conclusions to support decision-making and assay development. Work closely with cross-functional teams (Research, Process Development, Quality) to transfer methods, train operators and perform routine assay execution. Transfer assays to the Quality Control team, assist with drafting and reviewing qualification protocols, test methods, forms, and training outlines. Collaborate with the Quality team as necessary in the technical assessment of Out of Specification and Non-Conforming investigations. Participate in project-team meetings to present data and key findings. Support general lab and equipment maintenance tasks. Education & Experience Bachelor\'s degree with 5-7 years of relevant experience, and/or Master\'s degree in a relevant field with 2+ years of experience. Relevant fields include Molecular Biology, Immunology, Biomedical Engineering, or related fields. Hands-on experience with commonly used analytical methods such as flow, PCR, ELISA, and/or cell-based assays. Strong foundational knowledge and experience in handling human-derived cells with aseptic cell culture processing in ISO 5 biosafety cabinets. Understand \'why\' and not just the \'how\' of processes and practices. Knowledge, Skills, Abilities Excellent organization and time management skills. Strong communication, receptive to feedback, highly collaborative with the ability to adapt to change and work within a team. Ability to work within cross-functional teams and serve as AD lead on project teams. Attention to detail and ability to carry out standard procedures, follow company safety, training, and quality regulations. Working Conditions Office environment. Ability to lift up to 15 lbs. Flexibility to work after hours depending on business needs. Up to 10% of travel may be required. This position has not been approved for relocation assistance. Compensation And Benefits The hourly pay range estimated for this position based in California is $38.08–$58.50. 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 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 : #J-18808-Ljbffr Thermo Fisher Scientific
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