Senior Director, Manufacturing Jobs

Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity. In 2022, we generated revenue of $402 million and net income of $101 million.
We have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators. Our lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer and amyotrophic lateral sclerosis (“ALS”). We plan to initiate a Phase 2b trial in patients with non-alcoholic steatohepatitis (“NASH”) by the end of this year. Every year, we advance new molecules to the clinic.
Over the next few years, we expect to submit several new drug applications.
This position will provide leadership in the strategic planning and execution of Chemistry, Manufacturing and Controls (CMC) activities related to drug substance development and manufacturing.
Responsibilities

• Lead process development and manufacturing for drug substances and regulatory starting materials. Ensure that operational plans are consistent with overall regulatory and corporate strategies
• Develop strategies to ensure that supply chains for clinical and commercial drug substances are robust. Create risk mitigation plans to ensure that manufacturing timelines are consistent with overall corporate development timelines. Develop partner relationships with contract manufacturing organizations (CMOs).
• Assist with the preparation of the department budget. Manage budgets and collaborate with Finance to address budget variance.
• Collaborate with Regulatory to set CMC regulatory filing strategies and manage preparation and review of CMC sections of regulatory submissions.
• Lead group meetings and present CMC strategies and updates to larger groups.
• Manage commercial manufacturing of drug substances at CMOs, and lead projects associated with technology transfer and process validation.
• Position requires 15-20% travel.
• Manage, recruit, and support a team of professionals to achieve above duties.
• Manage process development and clinical manufacturing of drug substance at CMOs, as products transition from Phase 2 to Phase 3 and commercialization.
• Collaborate with other internal functional groups to ensure that manufacturing activities comply with cGMPs and regulatory filings. Facilitate the resolution of deviations in a timely manner.
• Manage Person-in-Plant coverage to provide adequate oversight for critical drug subtance manufacturing activities.

Preferred Education And Experience

• Experience in drafting Investigational New Product (IND) and New Drug Applications (NDA)sections, and oversight in new product launches.
• Must have experience in development of late phase small-molecule drug substances.
• In-depth knowledge of US and EU regulatory requirements for drug development and cGMPs.
• Expertise in evaluating, selecting and managing CMOs for late stage development and commercial manufacturing programs.
• Prior experience managing professional staff
• BS or MS in relevant scientific field. At least 12 + years experience in pharmaceutical development and manufacturing of small-molecule drug substances, with a minimum of 8 years experience in outsourced manufacturing environment.
• Expertise in process development, process validation and commercial manufacturing of small-molecule drug substance. Familiar with Design of Experiments, Quality by Design and Statistical process controls applications.
• Excellent communication and negotiation skills.
• Strong leadership and project management skills with ability to manage multiple technical projects successfully.

The pay range that the Company reasonably expects to pay for this position is $266,000 - $313,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered.
Applicants must be currently authorized to work in the United States on a full-time basis.
If you are based in California, we encourage you to read this important information for California residents linked here.
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 Employer