Corcept Therapeutics
Senior Process Engineer
Redwood City, California, United States · Senior · Full-time
Work authorization required$132k-$155kDetected 1 day ago
Data AnalysisExcelSupply ChainClinical TrialsGMPCommunicationOrganizational SkillsMicrosoft OfficeGxP
About the role
- 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.
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
- Collaborate closely with Analytical and Quality colleagues, providing technical expertise to drive CMO investigations/deviations to successful resolution
- 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
- 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
Requirements
- Must have high proficiency in the use of MS Office applications (Word, Excel, PowerPoint)
- BA/BS degree in a scientific/technical/engineering field
- Applicants must be currently authorized to work in the United States on a full-time basis.
- Working knowledge of documents related to GMP and development regarding Manufacturing, Analytical Development and Supply Chain
- Detail-oriented, highly organized, a good initiative with a customer-service attitude. Enjoy working independently
- Interested in learning about technical aspects of CMC activities
Nice to have
- Preferred Skills, Qualifications and Technical Proficiencies:
Skills
- https://www.corcept.com/
- Corcept is an Equal Opportunity Employer
Compensation
- The pay range that the Company reasonably expects to pay for this headquarters-based position is $131,600 - $154,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Benefits
- Assist in preparing reports detailing data analysis from manufacturing studies along with prospective solutions and benefits
- Preferred Education and Experience:
- 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.
Company info
- Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.
Visa & Work Authorization
- Applicants must be currently authorized to work in the United States on a full-time basis.
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This listing is sourced directly from Corcept Therapeutics's careers page and normalized into a canonical job model.