Who We Are:
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie )
About the Role:
Responsible for analytical development to support research and development, tech transfer and commercialization of drug substance and drug product processes, as well as oversight of batch testing/release and regulatory document contribution through managerial and individual input. Provides project management for analytical in support of Chemical and Product Development projects. Provides analysis and evaluation of material and products at all stages of the development process. Monitors and evaluates completion of tasks and projects. _
Your Contributions (include, but are not limited to):
Plans and manages projects. Represents Analytical Chemistry on cross-functional teams. Maintains accountability for analytical deliverables and progress on R&D and manufacturing 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
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 Chemical and Product 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
Other duties as assigned
Requirements:
BS/BA in Chemistry or related discipline AND 6+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR
MS/MA in Chemistry or related discipline AND 4+ years of experience OR
PhD in Chemistry or related discipline AND 2+ years of relevant experience; may include postdoc experience
Thorough understanding of analytical chemistry and a well-developed 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 transfer experience in Analytical Chemistry
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…