Associate Director, Manufacturing

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.What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.This position will manage contract development and manufacturing organizations (CDMOs) that produce small molecule Active Pharmaceutical Ingredients (API) in support of CTM and commercial supply. Responsibilities include managing CDMO business relationship, overseeing development and production activities of small molecule APIs at CDMOs, and providing technical support and troubleshooting, as well as authoring NDA/MAA.Responsibilities:Manage, oversee, and develop activities/processes at CDMOs in support of late phase and commercial small molecule APIs; Act as company liaison, person in plant, and point of contact for CDMOs. Review/approve manufacturing batch records, protocols, development reports, specifications and deviationsConduct technology transfer to CDMOs for Starting Material and API manufacturingLead process development, manufacturing, change control, troubleshooting manufacturing issues, investigations and resolution of deviations such as small molecule API products transition from Phase 2 to Phase 3 and validation at CDMOsDesign, implement, analyze and author protocols / reports for Proven Acceptable Range (PAR) Study experiments to optimize manufacturing processes; Collate manufacturing data to develop metrics, control charts and reports to improve manufacturing processesAssist with drug product development and manufacturing activities, as neededCollaborate with cross-functional CMC team per the following:Supply Chain: Work with Supply Chain organizations at Corcept and CDMO to ensure manufacturing schedules and forecasts are aligned to meet corporate needs, prepare requests for proposals and statements of works, source raw materials, identify activities or events that may critically affect supply and act on or relay that information to managementQuality: Work with Quality organizations at Corcept and CDMO to assure GMP standards are met and execute agreed-to Quality performance/improvement deliverables are completedRegulatory: Work with Regulatory organization to draft/review CMC sections of regulatory submissions including NDA/MAA and agency communicationsLegal/contractual: Enforce contractual commitmentsFinance: Assure that the financial terms and conditions of the Corcept-CMO relationship are being met by both partiesPrepare performance objectives for supplier and company. Trend important performance indicatorsRegular written communication via protocols, reports and standard operating procedures, change controls, and other related documentsPosition may require 20-25% travelPreferred Skills, Qualifications and Technical Proficiencies:Expertise in process development, process validation and commercial manufacturing of small molecule API. Familiar with Quality Risk Assessment, Design of Experiments, Proven Acceptable Range studies and application in late phase CMC developmentIn-depth knowledge of US and EU regulatory requirements for cGMPsExpertise in managing CMOs for late-stage development and commercial manufacturing programsStrong leadership and project management skills with ability to manage multiple technical projects successfullyProficient in analyzing technical data and preparing written technical reportsExcellent communication and negotiation skillsPreferred Education and Experience:B.S., M.S. or a Ph.D. degree in relevant scientific field7+ years' experience in pharmaceutical development and manufacturing, in an outsourced manufacturing environmentExperience in commercial manufacturing and development of late phase small molecule APIsThe pay range that the Company reasonably expects to pay for this headquarters-based position is $186,500 - $219,400; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.Applicants must be currently authorized to work in the United States on a full-time basis.For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.Please visit our website at: https://www.corcept.com/Corcept is an Equal Opportunity EmployerCorcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.