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 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 advance 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 Associate Director of Formulation Development will support the drug product development function. Responsibilities will include leading, planning and managing the technical and business-related activities associated with drug product development and manufacturing of solid oral dosage forms at contract development sites.
Responsibilities:
- Use knowledge and experience to design and select appropriate formulations for toxicology and first in human studies
- Support formulation and process development, technology transfer and clinical manufacturing activities
- Develop strategies and execute plans for drug product development in accordance with timelines and requirements of overall development programs
- Select and manage contract development and manufacturing vendors
- Negotiate and approve statements of work and quotes
- Review and approve manufacturing documents, protocols and reports
- Work closely with other internal functional groups to ensure that all drug product requirements for clinical trials are met
- Work closely with QA to ensure clinical supplies meet quality requirements
- Prepare CMC sections of regulatory filings.
- 15-20% travel expected
Preferred Skills, Qualifications and Technical Proficiencies:
- Technical expertise in solid oral dose formulations for small molecules
- Must have hands-on experience in formulating drugs with limited solubility and is knowledgeable about technologies employed to enhance bioavailability
- Must have experience in formulation and process development from early to late phase development
- Solid understanding of ICH, FDA, EMA guidance in CMC and Quality areas
- Good working knowledge of GMP requirements for drug product development and manufacturing
- Experienced in writing CMC sections of regulatory filings
- Strong written and oral communication skills. Must be comfortable making presentations in team meetings and must have the ability to communicate complex technical information clearly and concisely
- Good project management and leadership skills, with ability to lead multiple programs at the same time
- Enjoy working in a fast-paced environment within a matrix organization
Preferred Education and Experience:
- PhD in Pharmaceutical Sciences or relevant technical field with 6-8 years experience or MS with 10+ years experience.
- Minimum of 5 years in managing outsourced drug product development activities
The pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $213,000; 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.
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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
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