Introduction to role Neogene is seeking a motivated Process Engineer II with expertise in cell therapy to join our Manufacturing Sciences and Technology (MSAT) team. This role will support the production of clinical manufacturing products using a variety of modalities (autologous, allogeneic, TCR-T, and CAR-T). The process engineer will be a key subject matter expert supporting these clinical programs by providing manufacturing troubleshooting inputs and direction, authoring quality non-conformances and evaluations, and supporting technology transfers and process improvements. The successful candidate will have knowledge of basic engineering principles, cell therapy operations, and cGMP manufacturing. This role is based in Santa Monica, CA, and reports to the Associate Director, MSAT. There may be occasional project-specific travel requirements (Accountabilities Author and manage deviations, root cause analyses, product impact assessments, and change controls via the Quality Management System.Propose process and operational optimizations for ongoing cGMP manufacturing processes. Involves cell culture in multiple formats including flasks, bags, and bioreactors, and both non-viral and viral gene editing.Support technology transfer activities, leading cross-functional designees to coordinate Tech Transfer plan activities. Includes training oversight of new process steps to the manufacturing team (in collaboration with Process Development), authoring supporting protocols and summary reports and required risk assessments.Collaborate within the team to contribute to technical discussions.Review experimental proposals from Process Development, and cGMP batch records and SOPs for clinical manufacturing.Perform Person-In-Plant (PIP) duties for on-the-floor support of critical steps (when required).Perform other duties and special projects as assigned.Essential Skills/Experience Experience in cell and gene therapy or biologics manufacturing operations (required).Hands-on experience in cell and gene therapy (preferred).Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations (required).Knowledge of QbD, DOE, and statistical analysis tools (e.g., JMP, MiniTab) (preferred).Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning (required).Strong verbal and written communication skills, including technical writing (required).MS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology or related field with 2+ years relevant industry experience or BS degree with 4+ years relevant industry experience.Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
Sit and talk or hear.Frequently use hands to finger, handle, or feel.Occasionally stand, walk, and reach with hands and arms.Occasionally lift and/or move up to 10 pounds.Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.The noise level in the work environment is usually moderate.This position requires working with biological and/or chemical hazards.Ready to make a difference? Apply now!
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