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 (e.g., change controls, methods, monographs, protocols, and reports) and organize/archive documents in Veeva Quality Docs.
- Review analytical raw data in support of batch release and stability studies.
- Assist in authoring relevant sections (formatting/structuring of data) in support of regulatory filings.
- Draft, format, and route SOPs for analytical development and quality control.
- When needed, provide administrative support for analytical development activities.

Preferred Skills, Qualifications and Technical Proficiencies:
- Working knowledge of GMP and development documentation for Analytical Development and Quality Control.
- High proficiency with MS Office (Word, Excel, PowerPoint).
- Detail-oriented, highly organized, initiative-taking, customer-service attitude; enjoys working independently.

Preferred Education and Experience:
- BA/BS in a scientific/technical/engineering field.
- 6–8 years’ experience in Pharmaceutical Manufacturing and/or Analytical Development and/or Quality Control (or equivalent).

Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.