Corcept Therapeutics
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Manufacturing Engineer
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Corcept Therapeutics 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. This position will assist with managing contract development and manufacturing organizations (CDMOs) that produce small molecule Active Pharmaceutical Ingredients (API) in support of CTM and commercial supply. Responsibilities include performing batch record review, managing change controls, processing contracts, providing support with overseeing development and production activities of small molecule APIs at CDMOs, and contributing to support of on-site inspections by Regulatory Authorities. Responsibilities: Assist with managing development and manufacturing activities/processes at CDMOs in support of late phase and commercial small molecule APIs; may act as company liaison, person in plant. Review/approve manufacturing batch records, protocols, and development reports Manage the initiation and progression of control controls, resolution of deviations, among other quality events as small molecule API products transition from Phase 2 to Phase 3 and validation at CDMOs Support designing and implementing 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, 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: Provide support on work with Regulatory organization to draft/review CMC sections of regulatory submissions including NDA/MAA and agency communications Legal/contractual: Work with Legal to manage contracts including CDAs and MSAs as well as ensuring the enforcement of 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 Preferred Skills, Qualifications and Technical Proficiencies: Strong foundation in Chemical Engineering/Chemistry Ability to learn quickly in the area of process development, process validation and commercial manufacturing of small molecule API Knowledge of US and EU regulatory requirements for cGMPs Proficient in analyzing technical data and preparing written technical reports Excellent communication and negotiation skills Preferred Education and Experience: B.S. or M.S. degree in Chemical Engineering or Chemistry Prefer to have experience in pharmaceutical development and manufacturing of late phase small molecule APIs The pay range that the Company reasonably expects to pay for this headquarters-based position is $86,300 - $101,500; 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. Corcept is an Equal Opportunity Employer
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Manufacturing Engineer
role at
Corcept Therapeutics 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. This position will assist with managing contract development and manufacturing organizations (CDMOs) that produce small molecule Active Pharmaceutical Ingredients (API) in support of CTM and commercial supply. Responsibilities include performing batch record review, managing change controls, processing contracts, providing support with overseeing development and production activities of small molecule APIs at CDMOs, and contributing to support of on-site inspections by Regulatory Authorities. Responsibilities: Assist with managing development and manufacturing activities/processes at CDMOs in support of late phase and commercial small molecule APIs; may act as company liaison, person in plant. Review/approve manufacturing batch records, protocols, and development reports Manage the initiation and progression of control controls, resolution of deviations, among other quality events as small molecule API products transition from Phase 2 to Phase 3 and validation at CDMOs Support designing and implementing 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, 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: Provide support on work with Regulatory organization to draft/review CMC sections of regulatory submissions including NDA/MAA and agency communications Legal/contractual: Work with Legal to manage contracts including CDAs and MSAs as well as ensuring the enforcement of 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 Preferred Skills, Qualifications and Technical Proficiencies: Strong foundation in Chemical Engineering/Chemistry Ability to learn quickly in the area of process development, process validation and commercial manufacturing of small molecule API Knowledge of US and EU regulatory requirements for cGMPs Proficient in analyzing technical data and preparing written technical reports Excellent communication and negotiation skills Preferred Education and Experience: B.S. or M.S. degree in Chemical Engineering or Chemistry Prefer to have experience in pharmaceutical development and manufacturing of late phase small molecule APIs The pay range that the Company reasonably expects to pay for this headquarters-based position is $86,300 - $101,500; 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. Corcept is an Equal Opportunity Employer
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