Technical Development Principle Scientist

Responsibilities

• Serve as the analytical expert within a multi-disciplinary CMC team to support the development of clinical therapeutics (Phase 1-3).
• Design and execute analytical studies to support process development and enable successful regulatory filings (IND, BLA).
• Apply diverse analytical techniques including HPLC, LC-MS, capillary electrophoresis, and advanced spectroscopy.
• Present data at internal and external meetings to communicate findings and progress.
• Drive tasks to completion in a dynamic, fast-paced environment while working both independently and collaboratively.

Requirements

• Ph.D. with 4-6 years of additional experience, or M.S./B.S. with 6-10 years of additional experience in Analytical Chemistry, Biology, Biochemistry, Chemistry, Chemical Engineering, or a related discipline.
• Sound fundamental knowledge in the analytical characterization of proteins or related therapeutic modalities.
• Practical experience in high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), capillary electrophoresis, and advanced spectroscopy.
• Knowledge of CMC (chemistry, manufacturing, and control) development from Phase I through commercial stages.
• Strong organizational, oral, and written communication skills.

Preferred Qualifications

• Prior experience with small molecule linker drugs and antibody-drug conjugates (ADCs).
• Prior experience supporting IND-enabling and BLA-enabling activities.

About the Company

Genentech, a member of the Roche group, is a pioneer in the biotechnology industry. We are dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our mission is to transform society through scientific breakthroughs that improve lives globally.