Job reference #: CSBAY202101 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, CMC position to join our dynamic and highly collaborative team focused on the development of innovative next-generation cancer therapeutics. The Director, CMC will facilitate product development by leading the planning and execution of the chemistry, manufacturing, and control (CMC) strategy for all pipeline products. The individual will act as an advisor/liaison to senior management in order to plan, evaluate and recommend CMC strategy. As a key team member, this individual will have responsibility for hands-on management of CMC activities including selection of API manufacturers, drug substance manufacture, drug product formulation development and manufacture, contribution to regulatory submissions and interactions with regulatory authorities. Positions will be filled based on candidate’s level of experience. Responsibilities: • Develop CMC plans for all projects. • Lead projects from a technical perspective including API sourcing, drug formulation, analytical development, and drug product manufacturing. • Provide strong technical leadership and activity management to CDMOs to ensure API manufacture, drug product development and testing activities are in compliance with cGMP and regulatory requirements. • Provide technical expertise, and specialized knowledge in formulation development to support new drug products. • Provide oversight of drug product CMOs in production of early stage drug product for GLP studies and early clinical trials. • Write and review relevant sections of IND to support regulatory filings. Qualifications: • Ph.D. in Chemistry, Biochemistry, or related pharmaceutical science. • 8+ years of pharmaceutical industry experience in pharmaceutical product development, with experience managing CMC activities. Experience in both small and large molecule drug development is highly desirable. • In depth knowledge of cGMP practices, experience in oligonucleotides and/or PEGylation product is highly desirable. • Strong understanding of US and China pharmaceutical regulations. • Experience in managing CROs and CDMOs. • Experience in drafting relevant sections of IND to support regulatory filings. • Experience in drafting, reviewing, and submitting required documentation pertaining to the cGMP and GLP environment. • 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.