Manager, Analytical Development

Corcept Therapeutics • Redwood City, CA

2d • Onsite

About The Position

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. This position, reporting to the Sr. Director of Analytical Development and Quality Control, will be responsible for supporting analytical development activities for pharmaceutical drug substances and products.

Requirements

• Working knowledge of documents related to GMP and development regarding Analytical Development and Quality Control
• Must have high proficiency in use of MS Office applications (Word, Excel, PowerPoint)
• Detail-oriented, highly organized, good initiative with a customer-service attitude.
• Enjoy working independently

Responsibilities

• Provide analytical development support for drug substance and drug product manufacturing activities at Contract Manufacturing Organizations (CMOs), including development projects and routine manufacturing operations
• Review documents associated with drug substance and product development and manufacturing, including but not limited to change controls, methods, monographs, protocols, and reports, and organize and archive documents in Veeva Quality Docs System
• Review analytical raw data in support of batch release and stability studies
• Assist in authoring relevant sections, including formatting and structuring of data, in support of regulatory filings
• Assist in drafting, formatting, and routing of SOPs for analytical development and quality control
• When needed, provide administrative support for activities related to analytical development

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree