JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, bring our Mission to life every day to make the world healthier, cleaner, and safer! Our Advanced Cell Therapy group operates in a cGMP manufacturing facility on the UCSF Mission Bay campus in San Francisco. We provide pre-clinical development and clinical manufacturing services for cell therapies for a variety of unmet medical needs.
How will you make an impact?
As a member of the Analytical Development (AD) team, we apply technical skills to conduct experiments to support our 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.

Job Duties and 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 of study include Molecular Biology, Immunology, Biomedical Engineering, or other 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.

• 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