Senior Manager, Analytical Development and reputed company 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 reputed company 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, reputed company and collaborators continue to unlock the reputed company of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide reputed company of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the reputed company of cortisol modulation. The Senior Manager, Analytical Development and reputed company Control will manage outsourced analytical reputed company development and testing of drug reputed company 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 reputed company at contract laboratories. • Review analytical data from contract partners, reputed company feedback, and facilitate reputed company of technical or reputed company issues. • Manage release testing and stability testing of drug reputed company and drug product at contract laboratories. • reputed company CMO analytical deviation & reputed company event investigations, and reputed company 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 reputed company release of clinical products and reputed company 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 reputed company aspects of analytical testing for small molecule pharmaceutical products. • Experience in providing reputed company for product release and stability testing at contract manufacturers and laboratories. • Experience in facilitating reputed company of product investigations promptly. • Effective written and verbal communication skills. • reputed company in drafting regulatory submissions. • reputed company to manage multiple reputed company effectively. • Enjoy working independently and collaboratively as part of a CMC team. reputed company-to-haves • Ph.D. in reputed company or relevant field with 3+ years of development experience in the pharmaceutical industry or M.S. in reputed company or relevant field with 5+ years of development experience in pharmaceutical industry. • Excellent scientific knowledge of analytical reputed company and deep knowledge and experience of supporting pharmaceutical development and manufacturing of drug reputed company 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 Apply To this Job