Scientist, Biotechnology, Research Scientist

Position Details

Job Title: Scientist

Duration: 18 months contract, extendable up to 24 months

Location: San Francisco, CA

We are seeking a highly motivated, results-oriented, self-starter who demonstrates personal accountability for outcomes and thrives on increasing levels of responsibility, to join a new and dynamic team responsible for successful development and characterization of clinical-scale manufacturing processes for Chimeric Antigen Receptor T-cell (CART) therapies. The successful candidate will contribute to the development, implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes, and support successful tech transfer for GMP manufacturing and release at a CMO.

This position will also contribute to the development of Client technologies and approaches to meet future CART manufacturing needs and will work in close collaboration with key stakeholders including the CART Research and Bioprocess R&D groups.

• Actively contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes.
• Support clinical-scale non-GMP/GMP IND-enabling manufacturing operations, including tech transfer to CMO and support of successful GMP manufacturing of clinical material.
• Contribute to relevant and impactful innovation programs to enhance CART manufacturing technologies/capabilities and work-processes (such as alternate transfection/cell engineering strategies, media development, disposable/closed production systems and automation), aligned with emerging business drivers and regulatory expectations.
• Collaborate with Project Technical Teams and communicate effectively to ensure interaction with all stakeholder groups.
• Demonstrate strong personal leadership, accountability, and technical and interpersonal skills, applying scientific and technical experience to ensure safe, high‑quality lab practices.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and technical reports, and contribute to regulatory filings and responses to regulatory questions as appropriate.
• Present data and strategy to scientists (and management) in internal venues (technical meetings, project team meetings) as appropriate.

Education & Experience:

• BS or MS degree in Molecular Immunology, Molecular Biology, Bioengineering, or related field with a focus on cell and gene therapy.
• 3+ years of experience (1+ for MS) in a biotech/biopharma industry, preferably in development and characterization of manufacturing processes for cell- or gene‑based therapies.
• Process development for GMP manufacturing of cell- or gene‑therapies.
• Culture and characterization of primary T-cells, T-cell molecular biology/engineering.
• Aseptic cell culture technique.
• Direct experience with T-cell activation, viral transduction, and mRNA electroporation is highly desirable.
• Familiarity with cGMP and relevant regulatory guidance documents.
• Experience with single-use bioprocessing such as WAVE bioreactors and Clini
  
  MACS Prodigy.
• Process scale-up and scale-down experience.
• Knowledge of Design of Experiments.