Job Description

Senior Scientist

At CHR Life Sciences, we are excited to collaborate with a leading Biotechnology company based in the Bay area, currently in search of a senior scientist to join their analytical development team. As a senior scientist, you will play a pivotal role in executing characterization studies essential for establishing robust manufacturing control strategies. Your responsibilities will encompass drafting protocols and reports, as well as orchestrating the transfer of analytical methods to CROs/CMOs.

Key Responsibilities:

• Take the lead in developing, validating, and transferring analytical methods.
• Drive the development of analytical techniques and execute characterization studies to underpin raw material and formulation advancement.
• Provide expert oversight for drug substance release and stability testing.
• Assume authorship responsibilities for protocols, reports, and regulatory submissions as warranted.

The Ideal Candidate Will:

• Demonstrate proficiency in SEC-MALS methodology.
• Possess hands-on experience with state-of-the-art analytical apparatus (including HPLC, CE, SDS-PAGE, LCMS, and ELISA).
• Exhibit a track record of operating within regulated environments (GLP/GMP).
• Command knowledge of FDA, EU, and ICH regulatory frameworks.

Why Join: This presents a remarkable opportunity to become part of a rapidly evolving enterprise with ample prospects for career growth within the dynamic realm of biotechnology.

Key Technologies: SEC-MALS, Wyatt Technology, ASTRA software, HPLC, GMP, GLP, FDA, ELISA, Western Blot