Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.
We are looking for a talented and driven Cell Therapy Sr. Process Engineer / Scientist to be a core contributor to startup of Synthekine’s CAR-T (and TCR or TIL) cell therapy process development capabilities. The position will also collaborate within cross-functional project teams responsible for designing, analyzing, and optimizing cell therapy manufacturing processes for in-house execution or with CMO partners. The successful candidate will show broad aptitude towards current state of the art cell therapy equipment and processes, analytical controls, and manufacturing operations to support both early stage discovery programs and clinical through commercial manufacturing.
- Establish in-house cell therapy process capabilities suitable for development, optimization and manufacture of cell therapy product meeting clinically relevant yield and quality.
- Responsible for developing all aspects of cell therapy clinical process. Will assess parameter effects on process performance, establish optimal parameters and controls, design and execute phase appropriate process characterization experiments.
- Determine cell therapy equipment design and functional specifications appropriate for current and future cell therapy programs. Perform installation and maintenance of laboratory instruments and equipment.
- Originate and review protocols related to leukopak handling, cell isolation (MACS), activation, transformation (e.g. lentivirus), cell expansion, harvest, cryopreservation, and analytical release testing (e.g. cell count, FACS, etc.) for in-house and CMO based projects.
- Compile and analyze data for technical reports and presentations to support process decisions and facilitate active engagement with other scientific and technical stakeholders.
- Responsible for process transfer from small scale cell therapy laboratory formats to commercially feasible platforms with clinical regulatory compliance.
- Collaborate with research and discovery teams to: (i) identify the product’s critical quality attributes for manufacturing scale and (ii) evaluate existing and new equipment to modify or develop new processes and/o r transfer to and from CMO partners.
- Communicate experimental findings accurately and concisely in both oral and written form. Present at group meetings, project team meetings and company-wide meetings
- Advanced Degree in Engineering, Biochemistry, Immunology, or similar fields with 2+ years (Bachelor’s Degree with 4+ years considered) of cell therapy manufacturing and/or process development experience. Level will be commensurate with experience.
- Required expertise in clinical scale cell immunotherapy manufacturing or process development (i.e. human immune cell isolation, T cell activation, gene transfer, and cell culture expansion).
- Experience with cell immunotherapy analytical testing, including phenotyping, ddPCR, VCN, vector identification, mycoplasma, viability, etc.
- Understanding of protein upstream and downstream bioprocessing.
- Working knowledge of GMP, ISO, DOE, and QBD principles. Familiar with FDA requirements.
- Proficiency with at least some of the various cell therapy bioprocessing systems: G-REX, Prodigy, Wave-mixed Bioreactor, Cell Counter, Flow Cytometry, MACS, Metabolite Analyzer, ddPCR, VCN and vector identification, etc.
- Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment.
- Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.
Please apply at email@example.com.
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.