Senior Manager, Manufacturing

The posting, as Corcept Therapeutics wrote it

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.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com .

We are seeking an experienced Senior Manager, Drug Substance Manufacturing to support late-stage development and commercial readiness activities for small molecule active pharmaceutical ingredients (APIs) , including oversight of GMP API manufacturing and non-GMP starting material manufacturing activities. This role will be responsible for managing external manufacturing activities at contract manufacturing organizations (CMOs), supporting process validation and regulatory submission readiness, and ensuring robust execution of GMP manufacturing campaigns for late phase and commercial API programs as well as reliable supply of starting materials manufactured under non-GMP conditions.

The successful candidate will provide technical and operational leadership for drug substance manufacturing, process transfer, process validation, deviation investigation, change control, and continuous improvement activities. This position requires strong experience in small molecule API manufacturing, late-stage CMC development, GMP operations, and cross-functional collaboration with Quality, Regulatory, Supply Chain, Process Chemistry, Analytical Development, and external partners.

Responsibilities

• Lead and manage external GMP drug substance manufacturing activities for late phase small molecule API programs
• Oversee manufacture and supply of regulatory starting materials and key intermediates under non-GMP conditions, as applicable, to support late-phase API manufacturing programs
• Manage external partners involved in non-GMP starting material manufacture, including review of manufacturing plans, process descriptions, batch documentation, quality expectations, timelines, and supply readiness
• Partner with Process Chemistry, Quality, Regulatory, and Supply Chain teams to ensure appropriate control, documentation, qualification, and change management for starting materials used in GMP API manufacture
• Assess risks associated with starting material sourcing and manufacture, including supplier reliability, process consistency, impurity profile, traceability, and potential impact on downstream GMP API manufacturing
• Support supplier qualification, technical assessments, and lifecycle management activities for starting materials and key raw materials

[…]
amiliarity with expectations for starting material justification, supplier qualification, impurity control, traceability, and change control in late-phase or commercial API programs

• Solid understanding of cGMP requirements, ICH Q7, ICH Q11, process validation, and regulatory expectations for API manufacturing
• Experience with process transfer, scale-up, PPQ preparation, deviation investigations, CAPAs, and change controls
• Strong technical understanding of synthetic organic chemistry, impurity control, process parameters, in-process controls, and manufacturing documentation
• Experience contributing to CMC regulatory submissions and health authority responses is preferred
• Excellent project management, communication, technical writing, and cross-functional collaboration skills

The pay range that the Company reasonably expects to pay for this headquarters-based position is $173,430 – $204,030; 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

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