Manager, Analytical Development

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
• Affirmative action statement: Assist in authoring relevant sections, including formatting and structuring of data, in support of regulatory filings
• Affirmative action statement: 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

Requirements

• 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

Qualifications and Technical Proficiencies

• 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

Pay

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.

About the Role

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.

Benefits

Corcept is an Equal Opportunity Employer

Schedule

Headquarters-based position