Senior Scientist, Analytical Development
About The Position
Neurocrine Biosciences is a leading biopharmaceutical company 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 and a robust pipeline. This role is responsible for analytical development to support research and development, tech transfer, and commercialization of drug substance and drug product processes. It also involves oversight of batch testing/release, contribution to regulatory documents, and project management for analytical aspects of Chemical and Product Development projects. The position requires analysis and evaluation of materials and products throughout the development process and monitoring of task and project completion.
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.
Responsibilities
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
