Corcept Therapeutics

Director, Quality Control

Redwood City, California, United States · Director · Full-time

Work authorization required$215k-$253kDetected 1 day ago

Clinical TrialsExperimental DesignLeadershipCommunicationCollaboration

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.

Lead the QC function with primary responsibility for the design, execution, and oversight of stability programs
Review, trend, and maintain stability data. Alert the project team of any adverse trending
Collaborate with vendors and internal cross-functional teams to ensure that out-of-trend and out-of-specification results are addressed promptly
Oversee internal documentation to support retest periods and shelf-life extension based on data generated from ongoing stability studies
Support analytical project leads in preparation of batch analysis
Support analytical project leads in reviewing method validation protocols, reports, analytical method and test data
Manage data review qualifications of contract laboratories
Partner with the Sr Director of ADQC to build and enhance QC capabilities, infrastructure, and processes, with the expectation to progressively expand scope into broader QC oversight

Proven experience managing stability programs supporting late-stage development and global regulatory submissions
Experience in managing analytical testing in an outsourced environment
Experience in using statistical tools for data trend analysis and projection of drug substance retest period or drug product shelf-life
Excellent communication and collaboration skills with proven ability to work effectively with other functional groups
author and review stability sections required for regulatory submissions
Advanced degree in Analytical Chemistry or other relevant disciplines
Applicants must be currently authorized to work in the United States on a full-time basis.
S. in relevant scientific discipline. Advanced degree in Analytical Chemistry or other relevant disciplines
Strong technical expertise in stability study design, execution, and interpretation

The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300-$253,200; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

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.

Corcept is headquartered in Redwood City, California.
To learn more, visit www.corcept.com.
The position will provide strategic and organizational leadership for the Quality Control function supporting Corcept's development and commercial programs.
This position will have end-to-end oversight of all stability programs at contract laboratories and will author the stability sections of regulatory filings.
This position will partner closely with the Sr Director of Analytical Development & Quality Control (ADQC) to continuously strengthen, expand, and scale the QC function, with increasing responsibility across broader QC activities.
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.

Applicants must be currently authorized to work in the United States on a full-time basis.

This listing is sourced directly from Corcept Therapeutics's careers page and normalized into a canonical job model.