Corcept Therapeutics

This role will also provide support when needed for drug substance manufacturing, supply chain, and analytical development activities.. Review documents associated with drug product development and manufacturing, including but not limited to change controls, manufacturing batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System.. When needed, provide administrative support for activities related to packaging, supply chain, analytical development, and stability.. Working knowledge of documents related to GMP and development regarding Manufacturing, Analytical Development and Supply Chain.. 3-5 years' experience in Pharmaceutical Manufacturing or equivalent.

sr manufacturing engineer

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, reporting to the Sr. Director of Manufacturing, will be responsible for technical oversight of clinical and commercial manufacturing operations for pharmaceutical drug products. This role will also provide support when needed for drug substance manufacturing, supply chain, and analytical development activities. Responsibilities: <ul> <li>Support and oversee drug product manufacturing activities at Contract Manufacturing Organizations (CMOs), including development projects and routine manufacturing operations.</li> <li>Provide "person-in-plant" support to oversee critical manufacturing activities at CMOs as needed.</li> <li>Utilize technical expertise to troubleshoot manufacturing process issues.</li> <li>Collaborate closely with Analytical and Quality colleagues, providing technical expertise to drive CMO investigations/deviations to successful resolution.</li> <li>Assist in preparing reports detailing data analysis from manufacturing studies along with prospective solutions and benefits.</li> <li>Review documents associated with drug product development and manufacturing, including but not limited to change controls, manufacturing batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System.</li> <li>Assist in authoring relevant sections, including formatting and structuring of data, in support of regulatory filings.</li> <li>Assist in drafting, formatting, and routing of SOPs for manufacturing.</li> <li>Support activities to ensure Corcept complies with EHS requirements.</li> <li>When needed, provide administrative support for activities related to packaging, supply chain, analytical development, and stability.</li> <li>Support department approval of contracts and purchase orders.</li> </ul> Preferred Skills, Qualifications and Technical Proficiencies: <ul> <li>Working knowledge of documents related to GMP and development regarding Manufacturing, Analytical Development and Supply Chain.</li> <li>Must have high proficiency in the use of MS Office applications (Word, Excel, PowerPoint).</li> <li>Detail-oriented, highly organized, a good initiative with a customer-service attitude. Enjoy working independently.</li> <li>Interested in learning about technical aspects of CMC activities</li> </ul> Preferred Education and Experience: <ul> <li>BA/BS degree in a scientific/technical/engineering field.</li> <li>3-5 years' experience in Pharmaceutical Manufacturing or equivalent.</li> </ul> The pay range that the Company reasonably expects to pay for this headquarters-based position is $123,100- $144,900; 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 Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

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