Analytical Development Manager — GMP Drug Substance Excellence

Corcept Therapeutics; Redwood City (CA); On-site; USD 160,600 - 189,000; Full time

Job summary

Corcept Therapeutics is headquartered in Redwood City, CA, and seeks an experienced professional to support analytical development activities for drug substances and products, reporting to the Sr. Director of Analytical Development and Quality Control.

You will collaborate with CMOs, review GMP documentation, and help prepare data for regulatory filings. The role requires a BA/BS in a scientific field and 6–8 years in Pharmaceutical Manufacturing or Analytical Development, with strong MS Office

Qualifications

• Working knowledge of GMP and development documents for Analytical Development and Quality Control.
• Must have high proficiency in MS Office applications (Word, Excel, PowerPoint).
• Detail-oriented, highly organized, good initiative with a customer-service attitude. Enjoy working independently.

Responsibilities

• Provide analytical development support for drug substance and drug product manufacturing activities at CMOs, including development projects and routine manufacturing operations
• Review documents associated with drug substance and product development and manufacturing, including change controls, methods, monographs, protocols, and reports, and organize/archive 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

Skills

Detail-oriented

Organized

Customer-service attitude

Independent work

MS Office proficiency

Education

BA/BS degree in scientific/technical/engineering field

6-8 years experience in Pharmaceutical Manufacturing/Analytical Development/Quality Control

Tools

MS Office (Word, Excel, PowerPoint)

Job description

Corcept Therapeutics is headquartered in Redwood City, CA, and seeks an experienced professional to support analytical development activities for drug substances and products, reporting to the Sr. Director of Analytical Development and Quality Control.

You will collaborate with CMOs, review GMP documentation, and help prepare data for regulatory filings. The role requires a BA/BS in a scientific field and 6–8 years in Pharmaceutical Manufacturing or Analytical Development, with strong MS Office