Senior Manager, Analytical Development and Quality Control
About the position Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. The Senior Manager, Analytical Development and Quality Control will manage outsourced analytical methods development and testing of drug substance and drug product. The position will also be responsible for authoring technical reports, deviations, change controls, and analytical sections of regulatory filings. This is a hybrid role, typically on-site 3 days per week. Responsibilities • Manage the development, qualification, validation, and transfer of analytical methods at contract laboratories. • Review analytical data from contract partners, provide feedback, and facilitate resolution of technical or quality issues. • Manage release testing and stability testing of drug substance and drug product at contract laboratories. • Oversee CMO analytical deviation & quality event investigations, and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results. • Assist in the selection and management of contract laboratories. • Collaborate with other members of the CMC team to ensure timely release of clinical products and resolution of product investigations. • Author and review development reports, deviations, and change control documents. • Author and review analytical sections of regulatory submissions. Requirements • Experience in analytical and regulatory requirements, including strong working knowledge of cGMPs, ICH, USP, and other relevant regulatory requirements. • Good technical understanding of all aspects of analytical testing for small molecule pharmaceutical products. • Experience in providing oversight for product release and stability testing at contract manufacturers and laboratories. • Experience in facilitating resolution of product investigations promptly. • Effective written and verbal communication skills. • Experienced in drafting regulatory submissions. • Able to manage multiple projects effectively. • Enjoy working independently and collaboratively as part of a CMC team. Nice-to-haves • Ph.D. in chemistry or relevant field with 3+ years of development experience in the pharmaceutical industry or M.S. in chemistry or relevant field with 5+ years of development experience in pharmaceutical industry. • Excellent scientific knowledge of analytical chemistry and deep knowledge and experience of supporting pharmaceutical development and manufacturing of drug substance and various drug product dosage forms. • Must have hands-on experience with analytical development techniques used in the pharmaceutical industry including LC, LC-MS, GC, and Dissolution. Apply tot his job