Technical Operations Manager CMC

Role: Technical Operations Manager specializing in Chemistry, Manufacturing, and Controls (CMC) for development and commercial-stage biopharma or medtech products. Primary objectives include overseeing process development, validation, technology transfer, manufacturing, analytical support, and lifecycle management across medical device, pharmaceutical, and combination products. Responsibilities encompass supporting process characterization, scale-up, stability programs, managing change controls, deviations, and risk assessments, and ensuring compliance with regulatory standards (FDA, EMA, ICH, ISO). The role involves authoring technical documentation for global regulatory submissions, managing relationships with CMOs and internal labs, and handling operational activities such as material logistics and inventory control. Qualifications include a B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biomedical Engineering, with 10+ years’ experience in pharma, biotech, or medical device industries, and at least 5 years in CMC development, process validation, and regulatory support. Demonstrated success in managing external partners and cross-functional teams is essential. Preferred skills include technical writing, project management, and experience with process and analytical development, validation, and tech transfer. High-value specifics: focus on combination products, regulatory compliance, process validation, and lifecycle management in a global context. Work setup is hybrid out of Concord, CA, with up to 15% travel domestically and internationally.