Process Chemistry Senior Principal Scientist

Role Summary

Process Chemistry Senior Principal Scientist with deep knowledge of process chemistry for development of synthetic routes across early and late-phase development, delivering drug substance under tight timelines. Leads and mentors internal scientists, oversees resources, and collaborates with cross-functional teams to identify and optimize reaction conditions for key transformations and deliver APIs within specification ranges.

Responsibilities

• Demonstrates advanced intellectual and technical leadership
• Familiar with early and late phase pharmaceutical development and regulatory expectations
• Work with Pharm Sci team to develop project strategy, timelines, and leverages technical skills as a Process Chemistry expert within Vertex
• Individual lab work focused on developing safe, scalable processes
• Seek to employ state-of-the art technologies, including flow chemistry, photochemistry, electrochemistry, computational and predictive tools
• Will contribute directly to technology transfer to internal sites or external vendors
• Proactively identifies and oversees vendors to gain access to technologies as needed to deliver pipeline
• Leverage cross-functional knowledge to guide pharmaceutical sciences teams on potential impact of decisions
• Assesses data integrity to provide expert interpretation and recommendations to project teams and leadership
• Presents synthetic and experimental plans clearly and persuasively to all parts of the organization
• Recognized as a technical leader by the group and may mentor junior staff
• Authors publication, patent, and regulatory submissions

Qualifications

• Knowledge And Skills
  • Effectively managing CRO/CMO resources
  • Maintain standards for all laboratory records, internal reports, patents and external communications
  • Establishing and delivering on agreed timelines while integrating activities across various departments
  • May draft process descriptions for the CMC section of regulatory documents for early development projects
  • A track record of successfully achieving goals and solving problems in the pharma environment
  • Ability to communicate difficult concepts, ideas, and solutions to project teams and leadership
  • Knowledge and understanding regulatory factors and maintaining expert knowledge in chemistry
  • Other duties as defined

Education

• Bachelor's degree and 11+ years of experience or a Master's degree and 9+ years of experience or a PhD and 6-8+ years of experience in the pharmaceutical industry