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.

PREFERRED 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 development
• In-depth knowledge of US and EU regulatory requirements for cGMPs
• Expertise in managing CMOs for late-stage development and commercial manufacturing programs
• Strong leadership and project management skills with ability to manage multiple technical projects successfully
• Proficient in analyzing technical data and preparing written technical reports
• Excellent communication and negotiation skills

PREFERRED EDUCATION AND EXPERIENCE:

• B.S., M.S. or a Ph.D. degree in relevant scientific field
• 7+ years’ experience in pharmaceutical development and manufacturing, in an outsourced manufacturing environment
• Experience in commercial manufacturing and development of late phase small molecule APIs
  The 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/

• 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 deviations
• Conduct technology transfer to CDMOs for Starting Material and API manufacturing
• Lead 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 CDMOs
• Design, 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 processes
• Assist with drug product development and manufacturing activities, as needed
• Collaborate 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 management
• Quality: Work with Quality organizations at Corcept and CDMO to assure GMP standards are met and execute agreed-to Quality performance/improvement deliverables are completed
• Regulatory: Work with Regulatory organization to draft/review CMC sections of regulatory submissions including NDA/MAA and agency communications
• Legal/contractual: Enforce contractual commitments
• Finance: Assure that the financial terms and conditions of the Corcept-CMO relationship are being met by both parties
• Prepare performance objectives for supplier and company. Trend important performance indicators
• Regular written communication via protocols, reports and standard operating procedures, change controls, and other related documents
• Position may require 20-25% travel