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.
The Quality Operations Manager/Sr. Manager is responsible for managing a variety of operational activities to provide appropriate quality oversight of manufacturing activities at Corcept and Contract manufacturing Organizations (CMOs) by establishing and maintaining performance dialogue with suppliers including supplier evaluations and CMO/product/process risk assessments to ensure compliance for early phase development products through commercial products. The successful candidate will support the manufacture, testing, control, validation, labeling, and release of Corcept clinical and commercial drug substance, drug product, and finished goods supplies ensuring the products are in compliance with current Good Manufacturing Practices (cGMP) and are of the appropriate quality for their intended use.
Responsibilities:
- Lead QA operations oversight of Corcept and external partners processes to support various Chemistry, Manufacturing and Controls (CMC) projects
- Provide cGMP compliance support and guidance to cross functional team
- Work cross-functionally with the CMC group to provide oversight and support and manage review and approvals of change controls, deviations, CAPAs, and SOPs internally and externally
- Review and approve Master Batch Record (MBR) and executed batch records (EBR) and test data, and perform product disposition in compliance with cGMP regulations, regulatory filings, and quality agreements
- Review and approval of validation protocols and reports (e.g., process, method, cleaning, etc.)
- Lead and support supplier qualification
- Perform regular update of Quality Agreements
- Perform quality trends analysis and reports, recommending continual improvements opportunities
Preferred Skills, Qualifications and Technical Proficiencies:
- Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes
- Strong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical products
- Ability to work independently and communicate effectively with project team members and management groups and suppliers
- Work well in a project team environment with solid problem analysis and decision-making ability
- Ability to lead or support internal and external compliance audits of suppliers, CTLs, and CMOs
- Ability to work independently in addition to clearly and concisely communicate both in writing and verbally
- Ability to identify compliance risk and recommend mitigations
- Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations
- Strong statistical mindset and metric presentation
- Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio
- Travel required
Preferred Education and Experience:
- BS or MS degree in science, engineering or related field
- At least 10 years in the bio/pharmaceutical industry
- At least 5-10 years in Quality Assurance
- Knowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products
The pay range that the Company reasonably expects to pay for this headquarters-based position is $150,200 - $215,600; 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.
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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.
Top Skills
What We Do
Leading the field in the discovery of drugs that modulate the effects of cortisol.
The adverse effects of excess cortisol have been Corcept’s focus since the company’s inception. Abnormal levels and release of cortisol play a role in a variety of metabolic, oncological, and psychiatric diseases, and we are currently studying a new generation of compounds that may mitigate the effects of excess cortisol.
