Job ID :5579813004

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 such 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

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:

B.S., M.S. or a Ph.D. degree in relevant scientific field

7+ years experience in pharmaceutical development and manufacturing, in an outsourced manufacturing environment

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

$186,500 - $219,400; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Corcept is an Equal Opportunity Employer

Corcept Therapeutics

Latest Jobs

Associate Director, Manufacturing