Manager/Sr Manager, Packaging

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.

This position will be responsible for technical oversight of late-stage packaging development and operations for pharmaceutical drug products. Responsibilities include overseeing development and production activities at CMOs, providing technical support and troubleshooting, and supporting CMC sections of regulatory filings. This role will also provide support for drug product manufacturing, analytical development and stability, and supply chain activities as needed. This is a hybrid role typically requiring on-site presence 3 days per week.

Responsibilities:

• Subject Matter Expert (SME) for packaging of solid oral dosage products at Contract Manufacturing Organizations (CMOs)
• Manage all aspects of packaging operations at CMOs, including packaging development projects and commercial packaging operations
• Direct the design and implementation of new packaging configurations
• Direct packaging development, validation, shipping qualification, technology transfer, troubleshooting of packaging process issues, investigations and resolution of deviations as the program transitions from Phase 2 to Phase 3 and validation
• Provide "person-in-plant" support during project activities such as implementation/qualification of new packaging line equipment, packaging trials and validation, and introduction of component changes
• Assist with Supply Chain, Analytical, and Stability activities as needed
• Review/approve documents associated with drug product packaging, such as change controls, packaging batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System
• Collaborate with cross-functional teams as follows:
  • Supply Chain: Work with Supply Chain teams at Corcept and CMO to ensure packaging schedules and forecasts are aligned to meet corporate needs, support serialization implementation, and identify risks that may critically affect supply and escalate to management as needed
  • Analytical: Work with the Analytical team to provide packaging input for stability related issues
  • Quality: Work with the Quality organization at Corcept and CMO to ensure cGMP standards are met, investigation/deviations are closed in a timely manner, and facilitate batch release
  • Regulatory: Work with the Regulatory organization to support CMC sections of regulatory submissions including IND, IMPD, NDA, and MAA
  • Legal: Manage contractual commitments
  • Finance: Assure that the financial terms and conditions of the Corcept-CMO relationship are being met by both parties
• Regular written communication via protocols, reports and standard operating procedures, change controls, and other related documents
• The position may require 15-20% travel

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience in packaging development (bottles and blisters), validation, shipping qualification, serialization, and technology transfer of small molecule, solid oral dosage product packaging
• Working knowledge of US and EU regulatory requirements for cGMPs
• Experience in managing CMOs for late-stage development and commercial packaging programs
• Experience with drafting regulatory submissions such as IND, IMPD, NDA and MAA preferred
• Strong project management, business communication, and critical thinking skills with the ability to manage multiple technical projects successfully
• Strong in analyzing technical data and preparing written technical reports
• Has good general knowledge of other related disciplines
• Excellent communication and negotiation skills

Preferred Education and Experience:

• B.S. or M.S. degree in a relevant scientific field
• Experience in pharmaceutical packaging in an outsourced environment
  • Manager: 5-7 years
  • Sr. Manager: 7-10 years
• Must have experience in late-stage or commercial packaging of small molecule, solid oral dosage drug product

The pay range that the Company reasonably expects to pay for this headquarters-based position is $154,100 - $219,400; 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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