Scientist, Pharmaceutical Development

Role Summary

Scientist, Pharmaceutical Development responsible for supporting analytical development, method development and validation, and regulatory CMC documentation within a pharmaceutical development program. The role involves collaboration with Quality Assurance and contract laboratories to ensure program milestones are met and providing technical guidance on analytical methods.

Responsibilities

• Build strong working relationships with Pharmaceutical Development functional leads, Quality Assurance team, and third-party suppliers
• Support day-to-day management of contract laboratories performing analytical testing to ensure key program milestones are met
• Oversee stability programs including data management, analysis, and trending
• Identify out of specification and out of trend results and collaborate with contract organizations and internal Pharmaceutical Development and Quality Assurance teams to guide investigations
• Provide technical guidance during analytical method development and validation
• Author analytical CMC sections of regulatory filings to support on-going and future clinical programs
• Adequately escalate issues and risks to Senior Management and Pharmaceutical Development Leads

Qualifications

• Required: Bachelor's degree or above in Pharmacy, Chemistry, or related scientific discipline
• Required: Minimum 4 years of relevant experience working in a pharmaceutical development function, preferably analytical sciences
• Required: Prior experience in the management of contract laboratories performing routine and non-routine testing, method development, and validation
• Required: Strong working knowledge of cGxP requirements and relevant ICH and USP requirements
• Preferred: Working knowledge of JMP or other software for data trend analysis
• Preferred: Solid oral drug product and/or drug substance analytical sciences experience

Education

• Bachelor's degree or above in Pharmacy, Chemistry, or related scientific discipline