This position, reporting to the Sr. Director of Analytical Development and Quality Control, will be responsible for supporting analytical development activities for pharmaceutical drug substances and products.
Responsibilities:- Provide analytical development support for drug substance and drug product manufacturing activities at Contract Manufacturing Organizations (CMOs), including development projects and routine manufacturing operations
- Review documents associated with drug substance and product development and manufacturing, including but not limited to change controls, methods, monographs, protocols, and reports, and organize and archive documents in Veeva Quality Docs System
- Review analytical raw data in support of batch release and stability studies
- Assist in authoring relevant sections, including formatting and structuring of data, in support of regulatory filings
- Assist in drafting, formatting, and routing of SOPs for analytical development and quality control
- When needed, provide administrative support for activities related to analytical development
Preferred Skills, Qualifications and Technical Proficiencies:- Working knowledge of documents related to GMP and development regarding Analytical Development and Quality Control
- Must have high proficiency in use of MS Office applications (Word, Excel, PowerPoint)
- Detail-oriented, highly organized, good initiative with a customer-service attitude. Enjoy working independently
Preferred Education and Experience:- BA/BS degree in a scientific/technical/engineering field
- 6-8 years' experience in Pharmaceutical Manufacturing and/or Analytical Development and/or Quality Control or equivalent
The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,600 - $189,000; 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.
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