Principal Scientist, Analytical Development at Neurocrine Biosciences in San Diego, California

Posted in Other 11 days ago.





Job Description:

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.

What We Do:

Neurocrine Biosciencesis a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered inSan Diego,Neurocrine Biosciencesspecializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*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.

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Your Contributions (include, but 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 12+ 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 10+ years of experience OR


  • PhD in 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 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 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


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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.