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Associate Director/Director, Manufacturing

Employer
Corcept Therapeutics
Location
Menlo Park, CA
Start date
Nov 22, 2023

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At Corcept Therapeutics, we believe the potential impact of cortisol modulation on the future of health has long gone overlooked. That is why for twenty-five years we have pushed the boundaries of what is possible, driven by fiercely independent science, open collaboration and the curiosity to follow the data wherever it leads.

Our company is committed to building a culture that values diverse perspectives and the unique contributions of every employee. Our vibrant community is made up of over 300 people—medical practitioners, scientists, and industry professionals—all with the shared goal of advancing the science of cortisol modulation to treat serious disease.

Our work has uncovered over 1000 proprietary selective cortisol modulators, including our marketed product, Korlym® (mifepristone), the first treatment available for those living with Cushing’s syndrome, a life-threatening condition caused by excess cortisol activity. Today, we have a unique opportunity to revolutionize the treatment of severe endocrine, oncology, metabolism and neurology disorders and aim to deliver better outcomes for the people affected by them.

This position will manage contract development and manufacturing organizations (CDMOs) that produce small molecule Active Pharmaceutical Ingredients (API) in support of CTM and commercial supply.  Responsibilities include managing CDMO business relationship, overseeing development and production activities of small molecule APIs at CDMOs, and providing technical support and troubleshooting, as well as authoring NDA/MAA.

Responsibilities:                   

  • Manage, oversee, and develop activities/processes at CDMOs in support of late phase and commercial small molecule APIs; Act as company liaison, person in plant, and point of contact for CDMOs.  Review/approve manufacturing batch records, protocols, development reports, specifications and deviations;
  • Conduct technology transfer to CDMOs for Starting Material and API manufacturing
  • Lead process development, manufacturing, change control, troubleshooting manufacturing issues, investigations and resolution of deviations as small molecule API products transition from Phase 2 to Phase 3 and validation at CDMOs;
  • Design, implement, analyze and author protocols / reports for Proven Acceptable Range (PAR) Study experiments to optimize manufacturing processes; Collate manufacturing data to develop metrics, control charts and reports to improve manufacturing processes;
  • Assist with drug product development and manufacturing activities, as needed
  • Collaborate with cross-functional CMC team per the following:
    • Supply Chain: Work with Supply Chain organizations at Corcept and CDMO to ensure manufacturing schedules and forecasts are aligned to meet corporate needs, prepare requests for proposals and statements of works, source raw materials, identify activities or events that may critically affect supply and act on or relay that information to management. 
    • Quality: Work with Quality organizations at Corcept and CDMO to assure GMP standards are met and execute agreed-to Quality performance/improvement deliverables are completed;
    • Regulatory: Work with Regulatory organization to draft/review CMC sections of regulatory submissions including NDA/MAA and agency communications;
    • Legal/contractual: Enforce contractual commitments
    • Finance: Assure that the financial terms and conditions of the Corcept-CMO relationship are being met by both parties.
  • Prepare performance objectives for supplier and company. Trend important performance indicators.
  • Regular written communication via protocols, reports and standard operating procedures, change controls, and other related documents.
  • Position may require 20-25% travel, in the future.      

Preferred Skills, Qualifications and Technical Proficiencies:

  • Expertise in process development, process validation and commercial manufacturing of small molecule API. Familiar with Quality Risk Assessment, Design of Experiments, Proven Acceptable Range studies and application in late phase CMC development.    
  • In-depth knowledge of US and EU regulatory requirements for cGMPs.
  • Expertise in managing CMOs for late stage development and commercial manufacturing programs.
  • Strong leadership and project management skills with ability to manage multiple technical projects successfully.
  • Proficient in analyzing technical data and preparing written technical reports.
  • Excellent communication and negotiation skills.

Preferred Education and Experience: 

  • S. or M.S. or a Ph.D. degree in relevant scientific field. At least 7 years experience in pharmaceutical development and manufacturing, in outsourced manufacturing environment.
  • Must have experience in commercial manufacturing and development of late phase small molecule APIs.

The pay range that the Company reasonably expects to pay for this headquarters-based position is $190,000 - $215,000; 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.

If you are based in California, we encourage you to read this important information for California residents linked here.

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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