Essential Duties & Responsibilities:

• Develop analytical methods in a timely manner to support regulatory filings
• Contribute to drafting of documents for regulatory filings and responses to deficiencies
• Facilitate specification settings for drug substance and drug product
• Partner with development scientists, CROs and CMOs to ensure timely validation, transfer of analytical methods, and stability testing for new and existing products to support a timely FDA filing
• Support responses to comments from the FDA
• Provide technical feedback to request proposals from CROs and provide proposal comments
• Develop, review and approve protocols, reports and project schedules for projects
• Work within a cross-functional environment
• Lead laboratory operations and management, project proposals, budgeting and training activities
• Adjust work hours as needed to meet with global partners
• Support due diligence activities
• Some travel domestically/internationally may be required
• Other duties as assigned

Qualifications:

• Ability to work in a diverse and dynamic work environment
• Ability to manage a development project without oversight
• Demonstrated knowledge of pharmaceutical analytical methods development, validation, transfer,
• troubleshooting, specifications, stability and experimental design
• Demonstrated leadership experience overseeing scientists in development activities
• Strong experience in methods development, validation and troubleshooting in a GMP atmosphere
• Excellent written and verbal communication skills
• Excellent investigative and implementation skills
• Excellent time management and organizational skills
• Strong team player with a can-do attitude

Education & Experience:

• BA/BS/MA/MS or PhD degree in chemistry or analytical chemistry; Advanced degree (PhD) is preferred
• 5-10+ years of experience in the pharmaceutical industry
• Experience in parenteral pharmaceutical industry is a plus