Job reference #: CSBAY202103 Company Description: CS-Bay Therapeutics Inc. is a well-funded private biopharmaceutical company located in Newark, California that is dedicated to meet unmet medical needs with innovative therapeutics. Our projects are designed to harness multiple components of the immune system to combat a wide range of cancers. CS-Bay has a robust portfolio of fully-owned, novel drug candidates at various stages of discovery and development. Job Description: We are looking for qualified candidates for Associate Director/Director, Bioanalytical Development position to join our dynamic and highly collaborative team focused on the development of innovative next-generation cancer therapeutics. The Director, Bioanalytical Research will be responsible for developing bioanalytical strategies in supporting the evaluation of potential therapeutics for our development programs, including developing and validating preclinical and clinical methods to measure drug concentration and immunogenicity. Positions will be filled based on candidate’s level of experience. Key Responsibilities: • Provide scientific oversight of bioanalytical method development and validation; serve as a scientific resource to preclinical and clinical programs. • Collaborate and coordinate with team members across disciplines to drive bioanalysis strategies and resourcing. • Support integration of bioanalytical strategies and knowledge across development programs. • Plan, implement and execute bioanalytical PK, TE, PD, and immunogenicity assays to inform decision making and regulatory readiness. • Lead and coordinate sample testing, troubleshooting, reporting, and overseeing CROs. • Prepare, author and review bioanalytical sections (e.g., immunogenicity risk assessment, PK/PD) for regulatory filings globally and provide timely responses to regulator queries. Qualifications: • Ph.D. in the area of biochemistry, cellular or molecular biology, analytical chemistry, clinical pharmacology, immunology, or other related field. • 8+ years of relevant biotechnology or pharmaceutical industry experience in bioanalysis and/or related fields. • Demonstrated experience in managing contracted bioanalytical labs, and internal/external scientific collaborations • Extensive experience developing and applying novel reagents and methods to measure PK and immunogenicity in preclinical and clinical studies. • Experience across small and large molecule drug development. • Experience in oligonucleotides and/or PEGylation product is highly desired. • Advanced knowledge of assay development, qualification, validation, and regulatory standards for PK,TE, PD, and immunogenicity assays. • Understanding of regulatory approval processes (US and ex-US, IND/CTA and BLA/MAA) • Proven ability to author relevant bioanalytical sections of regulatory filings and respond to regulator queries. • Strong leadership, excellent oral and written communication skills, and enthusiasm for contributing in a fast-paced and innovative environment. • Fluency in Mandarin is desirable, but not required. What We Offer: CS-Bay Therapeutics Inc. offers a competitive salary and benefits package.