Senior Process Engineer
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. To learn more, visit www.corcept.com. This position, reporting to the Director of Manufacturing, will be responsible for technical oversight of clinical and commercial manufacturing operations for pharmaceutical drug products. This role will also provide support when needed for drug substance manufacturing, supply chain, and analytical development activities.
Requirements
- Working knowledge of documents related to GMP and development regarding Manufacturing, Analytical Development and Supply Chain
- Must have high proficiency in the use of MS Office applications (Word, Excel, PowerPoint)
- Detail-oriented, highly organized, a good initiative with a customer-service attitude. Enjoy working independently
- Interested in learning about technical aspects of CMC activities
- BA/BS degree in a scientific/technical/engineering field
- 3-5 years’ experience in Pharmaceutical Manufacturing or equivalent
- Basic knowledge of current Good Manufacturing Practice regulations
Responsibilities
- Support and oversee drug product manufacturing activities at Contract Manufacturing Organizations (CMOs), including development projects and routine manufacturing operations
- Provide “person-in-plant” support to oversee critical manufacturing activities at CMOs as needed
- Utilize technical expertise to troubleshoot manufacturing process issues
- Collaborate closely with Analytical and Quality colleagues, providing technical expertise to drive CMO investigations/deviations to successful resolution
- Assist in preparing reports detailing data analysis from manufacturing studies along with prospective solutions and benefits
- Review documents associated with drug product development and manufacturing, including but not limited to change controls, manufacturing batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System
- 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 manufacturing
- Support activities to ensure Corcept complies with EHS requirements
- When needed, provide administrative support for activities related to packaging, supply chain, analytical development, and stability
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What This Job Offers
Job Type
Full-time
Career Level
Senior
