Senior Manager, Analytical Development (Stability)

Location
Menlo Park, CA
Posted
May 12, 2022
Ref
4498836004
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

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.

The position will manage stability studies for drug substance and drug product for Corcept’s development and commercial programs. Responsibilities include review, trending, reporting, preparation of regulatory submission-ready data tables, and organization of the stability data provided by contract laboratories. As needed, the position may also manage the development and validation of outsourced analytical testing.

Responsibilities:

  • Manage stability studies conducted at external laboratories.
  • Review, trend, and maintain stability data and schedules in the LIMS system. Alert the project team of any adverse trending.
  • Collaborate with vendors and internal cross-functional teams to ensure that out-of-trend and out-of-specification results are addressed promptly.
  • Provide stability study progress summaries to project teams and ensure that stability reports are completed promptly.
  • Prepare internal documentation to support retest periods and shelf-life extension based on data generated from ongoing stability studies.
  • Assist in preparation of batch analysis and stability data tables required for regulatory submissions.
  • Assist analytical project leads in reviewing method validation protocols, reports, analytical method and test data.

Preferred Skills, Qualifications or Technical Proficiencies:

  • Good technical understanding of all aspects of stability study operation and stability study design.
  • Hands-on experience in managing stability programs supporting late stage product development and global registration submissions.
  • Experience in managing analytical testing in an outsourced environment.
  • Experience in using statistical software for data trend analysis and projection of drug substance retest period or drug product shelf-life
  • Strong written and oral communication skills with proven ability to work effectively with other functional groups. Detail oriented with excellent follow-through.

Preferred Education and Experience:

  • B.S. in relevant scientific discipline. Advanced degree in Analytical Chemistry or other relevant disciplines is preferred
  • Minimum of 5 years analytical stability experience in the pharmaceutical industry is required.
  • Experience with Labware LIMS system or equivalent 

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