Scientist II, Analytical Development

neurocrine; San Diego (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Neurocrine Biosciences in San Diego is seeking an Analytical project leader to drive analytical chemistry research, developing assays and supporting manufacturing of API and drug products for preclinical and clinical studies.

You will establish, validate, and document methods, ensuring regulatory compliance and quality throughout development and transfer processes. Strong cross-functional collaboration is essential.

Qualifications

• BS/BA in chemistry or closely related field with 5+ years in pharmaceutical analytical chemistry.
• MS/MA in chemistry with 3+ years in analytical chemistry is acceptable.
• PhD with relevant experience may substitute; strong knowledge of ICH/FDA guidance is required.

Responsibilities

• Act as an analytical project leader for API and drug product development.
• Develops, validates, and transfers analytical methods for drug substances and products.
• Oversees testing of analytical samples and ensures compliance with cGMP and regulatory requirements.
• Collaborates with cross-functional teams including pharmaceutical sciences and manufacturing.

Skills

Analytical chemistry

Project management

cGMP compliance

Problem solving

Regulatory understanding

Education

BS/BA in Chemistry

MS/MA in Chemistry

PhD in Chemistry

Tools

HPLC

Mass spectrometry

Regulatory compliance software

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:

Analytical project leader responsible in performing analytical chemistry research to develop assays based on new and existing methodologies. Responsible for all analytical activities for an assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases). Develops, establishes and validates testing methodology used to control raw materials, production intermediates and final products. Establishes, validates and documents new or existing compound specific methods. Conducts testing of analytical samples for the laboratory area, the separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Conducts work in the spirit of cGMP, with a focus on safety and regulatory requirements. _

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

• Act as an analytical project leader
• Responsible for all analytical activities for assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases)
• Develops and validates test methods at NBI for drug substances (API), intermediates and drug product
• Supports chemical development and formulation development
• Preformulation collaboration to Pharmaceutical Sciences
• Tests and provides a complete characterization of toxicology supplies
• Structural characterization of drug substance molecules, identification of impurities/degradants in API and drug product
• Audits and selects contract service providers (CSP) to conduct GMP analytical testing for Neurocrine projects
• Analytical technology transfer to CSP
• Overviews GMP analytical testing of clinical supplies by CSPs
• Facilitates and leads investigations for out of specification and out of trend results
• Prepares of the analytical sections of regulatory documents, protocols and reports
• Provides training and/or supervision to junior staff, as needed
• Other duties as assigned

Requirements:

• BS/BA degree in chemistry or closely related field AND 5+ years of experience in the pharmaceutical industry, focusing on analytical chemistry. Extensive hands-on experience in pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms. Previous supervisory and/or project management experience is preferred. OR
• MS/MA degree in chemistry or closely related field AND 3+ years of similar experience noted above OR
• PhD or equivalent in chemistry or closely related field AND some relevant experience; may include postdoc experience
• Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company
• Ability to creatively solve complex problems in a team environment
• Demonstration of cross-functional understanding related to drug development
• Effectively see projects to completion
• Understands how to effectively negotiate, persuade, and influence
• Extensive knowledge of pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms
• A working knowledge of regulatory requirements for drug product commercialization, NDA preparation and cGMP, including knowledge of quality assurance/ quality control practices and issues
• Must have working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD
• Demonstrates solid level of understanding project / group goals and methods
• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
• Able to explain the process behind the data and implications of the results
• Strong knowledge of one or more scientific disciplines, becoming expert in one discipline
• Strong knowledge of scientific principles, methods and techniques