Principal Scientist, Analytical Development

Neurocrine Biosciences • San Diego, CA

1d • $130,800 - $179,000

About The Position

Responsible for leading analytical development activities for multiple projects to support drug substance development from preclinical through commercial phase, with a focus on small molecules. Develops, establishes and validates testing methods used to control raw materials, in process testing, intermediates, API. Responsible for development and implementation of control strategies, with special emphasis on advancing innovation in analytical techniques. Responsible for keeping work in compliance with cGMP, safety and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.

Requirements

• BS/BA in Analytical Chemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field.
• Experience in method transfer in Analytical Chemistry OR MS/MA in Analytical Chemistry or related discipline and 10+ years of experience OR PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience
• Thorough understanding of analytical chemistry and a well-developed understanding of process chemistry
• Proficiency in one or more techniques for drug substance characterization, such as LC, GC, IR, MS, NMR, KF, UV etc.
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent laboratory and productivity skills
• Strong technical expertise in method development/validation/transfer experience in Analytical Development
• Good understanding of cGMP requirements in API and drug product
• Demonstration of cross-functional understanding related to drug development
• Assimilates data and research findings outside of Neurocrine for application to new scientific projects
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
• May develop an understanding of other areas and related dependencies
• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple programs, teams and/or departments
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills

Responsibilities

• Plans and manages projects.
• Represents Analytical Development on cross-functional teams.
• Maintains accountability for analytical deliverables and progress on CMC plans for all development projects
• Independently designs, plans and executes activities towards the goals of one or more analytical chemistry projects to support pre-clinical through commercial activities, as well as contributing to overall control strategy
• Supervises laboratory work and/or lab personnel and ensures safe laboratory practices
• Performs analytical development and optimizes methods in support of preclinical through commercialization
• Creates and implements novel ideas and techniques to support analytical activities with API Development
• Provides support for off-site analytical transfers, manufacturing support and interaction with contractors
• Provides input into CMC regulatory documentation and supporting work
• Provides effective supervision of laboratory personnel and guidance for their professional development
• Contributes to development of policies and department strategies
• Builds and enhances internal and external professional relationships
• Presents finding at varying levels across the company
• Supports career development and technical growth of direct reports
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Principal