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Manager, Analytical Development

Job Description:

This position is responsible for managing release and stability testing for small molecule drug substances and drug products for Corcept’s products under development. It will also support analytical method development and validation.


  • Manage stability programs for Corcept’s products in Phase 1 to marketed products. This includes review and approval of stability protocols and reports, review of stability data, and tracking of stability studies conducted at contract partners.
  • Assist in the method development, method validation and other drug substance or drug product analytical development activities.
  • Author or review stability sections of regulatory submissions. Prepare stability tables for regulatory submissions.
  • Review analytical data from contract partners, provide feedback and assist in timely resolution of technical or quality issues.
  • 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 OOS investigations.


  • Minimum B.S in Chemistry or relevant technical field with 7+ years experience in analytical development in the pharmaceutical industry. Advance degree in analytical chemistry or other relevant disciplines preferred.
  • Minimum 3 years experience managing contract testing laboratories.
  • Must have hands-on experience working in an analytical laboratory in the pharmaceutical industry.

Preferred Skills, Qualifications, or Technical Proficiencies:

  • Experience in analytical and regulatory requirements, including strong knowledge of cGMPs, ICH, USP and other relevant regulatory requirements.
  • Strong technical understanding of all aspects of analytical testing for small molecule products.
  • Experience in providing oversight for product release and stability testing at contract manufacturers and contract testing laboratories
  • Detail oriented, excellent follow-through, and persistent in ensuring that investigations are resolved in a timely manner.
  • Effective communication, collaboration and negotiation skills.
  • Able to handle multiple projects effectively. Enjoy working independently.

If you are interested, please submit your resume by email to

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