At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder's world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Respect, Science, Courage and Collaboration, and it reflects who we are and the environment we are creating. Position Summary: The Senior Scientist, Analytical Development (AD) will be responsible for helping to build the technical expertise within the analytical development team at Lyell. As a leader of the molecular biology group, this role will be actively involved in developing analytical testing methods, assessing new technologies, and designing/executing experiments to support process development and release and characterization testing of engineered T-cell products. This includes the establishment of various technologies, such as qPCR and/or ddPCR to assess viral vector components, development of residual host cell DNA and protein assays and transcriptional analyses. Additional responsibilities include the training and mentoring of other AD scientists, qualification and technology transfer of test methods to the QC testing facility and other key projects as required to help build and grow the analytical development division. We are recruiting a talented and experienced Sr. Scientist for our Analytical Development group to help build our expertise within the Technical Operations organization. This individual will work closely with the Director of AD to develop a high functioning and dynamic group, including establishment of the infrastructure (technology and equipment), hiring and training members of the team and assisting in the tech transfer of CAR-T-based analytical methodologies into a new GMP manufacturing and QC testing facility. The successful candidate will have experience in AD activities in the cell and gene therapy space (preferably), ability to mentor scientists, experience with assessing new technologies, experience with CMC project timelines and activities and a thorough understanding of the technological requirements to execute on the analytical testing and characterization needs of a cellular therapy company Essential Functions: + Design, develop, execute and document analytical testing methods to study and characterize processes for production of T cell therapies, primarily focused on molecular biology-based techniques, such as qPCR, ddPCR, Vector Copy Number (VCN) assessment, residual protein and host cell DNA assessments. + Author, review and revise test methods and standard operating procedures (SOPs) + Partner in the qualification and technology transfer of assays to QC, and support future assay validation and assay troubleshooting + Participate in the recruitment and training/mentoring of other analytical scientists, determine critical equipment and technology needs and infrastructure and build relationships with key stakeholders, including research, process development and quality control functions + Provide analytical support in cross-functional project teams, investigation teams and CMC teams + Lead analytical projects including but not limited to development of analytical control strategies and heightened characterization of cell therapy products + Serve as key technical resource for the evaluation of new analytical technologies and their implementation within the AD group + Develop and deliver scientific presentations, prepare clear and concise technical reports, participate in project teams, and contribute to regulatory filings + Lead product characterization activities, including comparability assessments in support of product life cycle management + Contributes to building a culture that encourages continuous learning, improvement and innovation, and encourages team members to expand their technical skill base Requirements Preferred Experience: + A minimum of 5 years of experience in analytical development, cGMP QC testing and/or CMC development or other relevant discipline(s) + Technical expertise with qPCR, ddPCR, flow cytometry, cytokine analysis, gel electrophoresis and other molecular assays + Experience in analytical development and qualification, cGMP QC testing and implementation of new technologies in a regulated environment (e.g., GMP, GLP, GxP) + Experience with the assessment of new technologies in a fast-paced, learning organization; preferably in a cross-functional setting where impact of new technologies are evaluated across research, development and commercial organizations + Prior experience in either design, qualification, start-up of analytical development labs preferred + Cell therapy experience Preferred Education: + Ph.D. in Molecular/Cellular Biology, Immunology, Biochemistry, Biology or equivalent relevant industry experience with a MS or BS degree Preferred Additional Skills: + Must have excellent oral and written communication skills + Ability to work independently and collaboratively among cross-functional teams + Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities + Excellent analytical skills and scientific/technical expertise Benefits At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited or unable to access or use this online application process and need an alternative method for applying, please contact us via our company website.