Senior Manager/Associate Director, Analytical Development

Corcept is engaged in the discovery and development of drugs that 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 addition to our commercial product, Korlym, we have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  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, weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis (“NASH”).  We are about to start a Phase 2 trial in patients with amyotrophic lateral sclerosis (“ALS”).

In 2021, we generated revenue of $366 million and net income of $112 million.

This position 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.

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 product and drug substance at contract laboratories.
• Assist in selection and management of contract laboratories.
• Collaborate with other members of CMC team to ensure timely release of clinical products and resolution of product investigations.
• Author and review technical reports, deviations, and change control documents.
• Author and review analytical sections of regulatory submissions.

Preferred Skills, Qualifications or Technical Proficiencies:

• 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 in a timely manner.
• 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.

Preferred Education and Experience:

• B.S. in Chemistry or relevant technical field, advanced degree preferred.
• A minimum of 7 – 10 years experience in analytical development of new chemical entities in the pharmaceutical industry including managing methods development, validation, and testing at contract testing laboratories.
• Must have hands-on experience with analytical development techniques used in pharmaceutical industry including LC, LC-MS, GC, and Dissolution.

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