For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that, when unregulated, can play a role in a broad range of diseases.Corcept is headquartered in Redwood City, California. This position, reporting to the Director of Manufacturing, will be responsible for technical oversight of clinical and commercial manufacturing operations for pharmaceutical drug products. The role will also provide support when needed for drug substance manufacturing, supply chain, and analytical development activities.ResponsibilitiesSupport and oversee drug product manufacturing activities at Contract Manufacturing Organizations (CMOs), including development projects and routine manufacturing operationsProvide person‑in‑plant support to oversee critical manufacturing activities at CMOs as neededUtilize technical expertise to troubleshoot manufacturing process issuesCollaborate closely with Analytical and Quality colleagues, providing technical expertise to drive CMO investigations/deviations to successful resolutionAssist in preparing reports detailing data analysis from manufacturing studies along with prospective solutions and benefitsReview 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 SystemAssist in authoring relevant sections, including formatting and structuring of data, in support of regulatory filingsAssist in drafting, formatting, and routing of SOPs for manufacturingSupport activities to ensure Corcept complies with EHS requirementsWhen needed, provide administrative support for activities related to packaging, supply chain, analytical development, and stabilityPreferred Skills, Qualifications and Technical ProficienciesWorking knowledge of documents related to GMP and development regarding Manufacturing, Analytical Development and Supply ChainMust have high proficiency in the use of MS Office applications (Word, Excel, PowerPoint)Detail‑oriented, highly organized, a good initiative with a customer‑service attitude, enjoys working independentlyInterested in learning about technical aspects of CMC activitiesPreferred Education and ExperienceBA/BS degree in a scientific/technical/engineering field3‑5 years' experience in Pharmaceutical Manufacturing or equivalentBasic knowledge of current Good Manufacturing Practice regulationsThe pay range that the Company reasonably expects to pay for this headquarters‑based position is $131,600 – $154,900; 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.For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.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: is an Equal Opportunity EmployerCorcept 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.#J-18808-Ljbffr