Principal Scientist, Chemical Development

Role Summary

Responsible for research and development, tech transfer and commercialization of drug substance processes, as well as oversight of batch manufacturing and regulatory document contribution through managerial and individual input. Provides project management for CMC programs or Chemical Development projects. Manages direct reports.

Responsibilities

• Plans and manages projects. Represents Chemical Development on cross-functional teams. Maintains accountability for deliverables and progress on R&D and manufacturing plans for Chemical Development projects
• Independently designs, plans and executes activities towards the goals of one or more Chemical Development projects to support preclinical through commercial activities
• Supervises laboratory work and/or lab personnel and ensures safe laboratory practices
• Performs process R&D and optimizes synthetic routes
• Identifies and recommends approaches to novel ideas in Chemical Development
• Provides support for off-site synthesis, manufacturing activities and interaction with contractors
• Provides input into CMC regulatory documentation and supporting work
• May provide supervision of laboratory personnel and guidance for their professional development
• Contributes to development of policies and executes against department strategies
• Builds and enhances internal and external professional relationships
• Other duties as assigned

Qualifications

• Required: BS/BA in chemistry and 12+ years of experience in pharmaceutical/process development field, including API manufacturing experience; experience managing laboratory and maximizing productivity
• Required: MS/MA in chemistry and 10+ years of similar experience
• Required: PhD in chemistry and 4+ years of similar experience; may include postdoc experience
• Required: Thorough understanding of organic chemistry and process chemistry; strong knowledge of current literature
• Required: Excellent laboratory and productivity skills
• Required: API Manufacturing experience
• Required: Good understanding of cGMP requirements in API
• Required: Demonstration of cross-functional understanding related to drug development
• Required: Ability to assimilate data and research findings outside of Neurocrine for application to new scientific projects
• Required: Broad knowledge of scientific principles; intellectual mastery in at least one scientific area
• Required: Advanced knowledge and ability working with a variety of laboratory equipment/tools
• Required: Ability to work as part of and lead multiple teams; leadership capability
• Required: Excellent computer skills; strong interpersonal, communication, problem-solving and analytical thinking
• Required: Ability to see broader impact across programs, teams and/or departments; ability to meet multiple deadlines with accuracy and efficiency
• Required: Excellent project management skills

Skills

• Excellent computer skills
• Excellent interpersonal, communications, problem-solving, and analytical thinking skills
• Strong leadership and collaboration abilities; capacity to lead indirect teams
• Effective cross-functional communication and relationship-building

Education

• BS/BA in chemistry; MS/MA in chemistry; or PhD in chemistry