Senior Scientist, Analytical Development

neurocrine; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Neurocrine Biosciences, a leading biopharmaceutical company, is seeking an analytical development leader in California to oversee drug substance and drug product analytics, tech transfer, and regulatory contributions. The role provides project management for Analytical Chemistry across multiple development projects from pre-clinical through commercialization.

Responsibilities include supervising lab personnel, designing and executing analytical activities, and contributing to CMC regulatory

Qualifications

• BS/BA in Chemistry or related discipline AND 12+ years of experience in analytical/pharmaceutical development.
• MS/MA in Chemistry or related discipline AND 10+ years of experience.
• PhD in Chemistry or related discipline AND 4+ years of relevant experience; postdoc may apply.

Responsibilities

• Plans and manages projects; represents Analytical Chemistry on cross-functional teams.
• Independently designs and executes activities for analytical chemistry projects.
• Supervises laboratory work and ensures safe practices.
• Performs analytical development and optimizes methods from preclinical to commercialization.
• Contributes to regulatory documentation and supports tech transfers.
• Provides guidance for professional development of lab personnel.
• Builds internal/external relationships and supports department strategies.

Skills

Analytical Chemistry

Project Management

Leadership

Laboratory Skills

Communication

Education

PhD in Chemistry or related discipline

MS/MA in Chemistry or related discipline

BS/BA in Chemistry or related discipline

Tools

Analytical instrumentation

cGMP knowledge

Job description

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 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
• #LI-LS1

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment , and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't li