Corcept Therapeutics

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.. 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.. Assist in drafting, formatting, and routing of SOPs for analytical development and quality control.. Working knowledge of documents related to GMP and development regarding Analytical Development and Quality Control.. 3-5 years' experience in Pharmaceutical Manufacturing and/or Analytical Development and/or Quality Control or equivalent.

senior analytical chemist

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
This position, reporting to the Senior Director of Analytical Development, will be responsible for supporting analytical development and quality control activities for pharmaceutical drug substances and products.
Responsibilities:
Provide analytical development and quality control 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 and stability.
Preferred Skills, Qualifications and Technical Proficiencies:
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.
Interested in learning about technical aspects of CMC activities
Preferred Education and Experience:
BA/BS degree in a scientific/technical/engineering field.
3-5 years' experience in Pharmaceutical Manufacturing and/or Analytical Development and/or Quality Control or equivalent.
Basic knowledge of Good Manufacturing Practice regulations.
The pay range that the Company reasonably expects to pay for this headquarters-based position is $123,000-$144,000 the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
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
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

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