Manager, Analytical Development

The position will manage stability studies for drug substance and drug product for Corcept’s development and commercial programs. Responsibilities will include reviewing, 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 development and validation of outsourced analytical testing.

Responsibilities:

• Manage stability studies conducted at external laboratories.
• Create studies, enter/review/trend and maintain stability data and schedules in LIMS system. Alert 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 in a timely manner.
• Provide stability study progress summaries to project teams and ensure that stability reports are completed in a timely manner.
• Prepare internal documentation to support retest periods and shelf-life extension based on data generated from on-going 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.
• Assist with monthly tracking of financial accruals for analytical activities.

Preferred Skills, Qualifications and Technical Proficiencies:

• Good understanding of cGMP and 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 or stability studies in an outsourced environment.
• Experience in using statistical software (JMP) 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.
• Proficient in computer skills including applications in Microsoft Office.

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 Software or equivalent desired

The pay range that the Company reasonably expects to pay for this position is $144,000 - $170,000; 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.

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