Principal Scientist, Drug Product Process Science (Biotech)

TL;DR

Principal Scientist, Drug Product Process Science (Biotech): Leading drug product process characterization and BLA readiness for allogeneic CAR-T therapies with an accent on regulatory-ready documentation and process design. Focus on designing DOE strategies, establishing scale-down models, and authoring BLA-enabling technical documents.

Location: South San Francisco, CA. Must be authorized to work in the U.S.

Salary: $155,000 - $180,000 per year

Company

A clinical-stage biotechnology company pioneering allogeneic CAR T cell products for cancer and autoimmune disease.

What you will do

• Design and execute Drug Product process characterization strategies using DOE to enable BLA submission.
• Establish and qualify representative scale-down models (SDMs) in support of drug product process design.
• Develop in-use compatibility studies and collaborate with Clinical Operations on the development and management of DAI and IPM.
• Lead the development of DP data organization, analysis, and visual workflows for regulatory readiness.
• Provide technical leadership and person-in-plant support for large-scale manufacturing runs.
• Author and review BLA-enabling technical documents, including risk assessments, protocols, and Module 3 DP sections.

Requirements

• Ph.D. in Pharmaceutics, Immunology, biomedical engineering, or related field (7+ years exp), or MS (10+ years), or BS (12+ years) of industry experience.
• Experience in new product development, process characterization, formulation development, and statistical design of experiments.
• Hands-on experience using Quality-by-Design (QbD) principles for autologous and/or allogeneic cell therapies.
• Proven track record contributing to regulatory submissions such as IND or BLA.
• Proficiency in statistical software such as JMP.
• Must be authorized to work in the U.S.

Nice to have

• Experience with electronic data systems and ELNs such as Benchling.
• Broad experience in pharmaceutical development.

Culture & Benefits

• Collaborative work environment with a team of talented scientists.
• Comprehensive compensation package including an annual performance bonus and equity.
• Full health insurance coverage.
• Generous time off, including two annual company-wide holiday shutdowns.