Sr. Principal Scientist, Analytical Development; Molecule San Diego

Overview

Who We Are:

At Neurocrine Biosciences, we pride ourselves on a strong, inclusive culture based on our purpose and values. We are passionate about our people as we are about our purpose—to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We discover and develop life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington s disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, and a robust pipeline.

For three decades, we apply our neuroscience insight to treat complex conditions. For more information, visit , follow on Linked In, X and Facebook. (Abb Vie collaboration)

About the Role: Responsible for leading a sub-team in analytical development and/or serving as an analytical lead for multiple projects to guide analytical activities for supporting drug substance and drug product development from preclinical through commercial. Develops, establishes and validates testing methods to control raw materials, in-process testing, intermediates, API and drug products. Responsible for development and implementation of control strategies, with emphasis on advancing innovation in analytical techniques.

Ensures work complies with cGMP, safety and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development. Monitors and evaluates completion of tasks and projects.

Your Contributions (include, but are not limited to):

• Leads and manages multiple projects. Represents Analytical Development on cross-functional teams. Maintains accountability for analytical deliverables and progress on CMC plans for all development projects
• Manages designs, plans and executes activities towards goals of one or more analytical development projects to support pre-clinical through commercial activities
• Directs 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 Chemical and Product Development
• Develop and support off-site analytical transfers, manufacturing support and interaction with contractors
• Supplies input into CMC regulatory documentation and supporting work
• Facilitates effective supervision of laboratory personnel and guidance for their professional development
• Leverages literature, ICH/ Regulatory guidance, and practical experience to perform their work and influence CMC strategies
• Contributes to development of policies and department strategies
• Builds and enhances internal and external professional relationships
• Supports career development and technical growth of direct reports
• Presents finding at varying levels across the company
• Other duties as assigned

• BS/BA in Analytical Chemistry or related discipline and 15+ 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 13+ years of experience OR
• PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience
• Expert knowledge and understanding of analytical chemistry and a thorough understanding of process chemistry as well as formulation development
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent laboratory and productivity skills
• Method development, validation, and transfer experience in Analytical Development
• Comprehensive understanding of cGMP requirements in API and drug product
• Expert knowledge of cross-functional understanding related to drug development
• Applies understanding of the team s place in the larger organization
• Maintains substantial knowledge of principles and theories and acts as a technical lead on various…