Principal Scientist, Drug Substance-Process Science/Immunology
$155,000–$180,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Lead high-impact Cell Starting Material characterization studies using QbD principles to elucidate dependencies between starting material and drug product quality attributes. Evaluate and develop innovative cell isolation technologies while driving process understanding and control strategy development for clinical and commercial manufacturing. Interpret complex datasets to propose and implement innovative solutions for process risks and opportunities. Serve as a subject matter expert in cell therapy process sciences, providing technical leadership, mentoring scientists on study design, and collaborating cross-functionally with R&D, Analytical Sciences, and Regulatory teams. Prepare technical reports, regulatory documents, and scientific publications to support program execution.
Required Qualifications
- Ph.D. in Molecular & Cell Biology, Immunology, or a related field with at least 7 years of relevant experience
- MS with at least 10 years of industry experience
- BS with at least 12 years of industry experience
- Candidates must be authorized to work in the U.S.
Desired Qualifications
- Desired expertise in immunology and/or cellular biology
- Demonstrated expertise in aseptic technique, cell-based assays, and cell culturing
- Experience in cell isolation and enrichment from a variety of biological sources
- Experience with cell isolation technologies for cell therapy
- Experience optimizing cryopreservation media and processes
- Strong analytical mindset for interrogating datasets
- Demonstrated experience building robust experimental frameworks to interrogate biological systems, with a strong emphasis on interdependencies among different cell types, process characterization, DOE, and data-driven decision-making
- Strong understanding of cell therapy manufacturing processes (e.g., gene editing, viral transduction, cell expansion, formulation)
- Proven track record of leading complex technical programs and cross-functional initiatives
- Strong leadership, mentorship, and cross-functional collaboration skills
- Strong written and verbal communication skills, including authoring technical documents and presenting to senior leadership
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.