Senior Scientist, Analytical Development (Small Molecule)

About this role

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 patients with 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: The Senior Scientist, Analytical Development, is responsible for analytical development activities for small molecule drug substances from preclinical through commercial phase. This role is laboratory-focused, requiring deep expertise in analytical chemistry and strong problem-solving skills. The Senior Scientist independently manages analytical activities for assigned programs including development, execution, validation, transfer and troubleshooting of methods used to control raw materials, in-process, intermediates and final products. While also overseeing analytical work performed at external CROs and CDMOs. Conducts work in compliance with cGMP, safety, and regulatory requirements.

The position works cross-functionally with teams across CMC, Technical Operations, Quality, Regulatory Affairs, Manufacturing, and external partners to support product development, manufacturing readiness, and regulatory submissions. The role also contributes to overall control strategy development and ensures scientific and technical alignment through all phases of product development. _ Your Contributions (include, but are not limited to): • Perform development and optimization of phase-appropriate analytical methods for starting materials, intermediates, and drug substances to support programs from early development through commercialization using techniques such as HPLC, GC, MS, IC, FTIR, UV, NMR, KF and other relevant techniques to ensure method suitability for intended purpose

• Perform analytical method verification and validation within cGMP compliance and in accordance with regulatory guidelines

• Perform analytical development activities for the characterization of small molecules utilizing various chemical-physical characterization techniques

• Perform development stability studies, forced degradation studies and support impurity identification

• Independently lead and execute analytical development activities and contribute to overall control strategy for assigned projects

• Provide scientific leadership and technical support for quality investigations, including OOS/OOT events, deviations, root cause analyses, and CAPAs

• Maintain accurate and comprehensive laboratory documentation in compliance with company procedure

• Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects

• Conduct laboratory work independently and/or train lab personnel within the company and at external vendors

• Support CMC regulatory documentation and filings as needed

• Support off-site analytical transfers, manufacturing support, and interaction with contractors

• Clearly communicate analytical results, risks, and recommendations through high-quality technical reports, presentations, and cross functional discussions across the company

• Ensure safe laboratory practices

• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development

• Contribute to development of policies and department strategies

• Partner closely with other team members to develop and implement best practices

• Build and enhance internal and external professional relationships

• Support career development and technical growth of team members

• Performs other duties as assigned

Requirements: • BS/BA in Chemistry/Biochemistry/ or related discipline and 5+ years of experience in the analytical/pharmaceutical development field. Hands-on experience in method development, validation, transfer and execution in Analytical Chemistry OR

• MS/MA in Chemistry or related discipline and 3+ years of experience OR

• PhD in Analytical Chemistry or related discipline and some relevant experience; may include postdoc experience

• Strong technical expertise in testing, method development, verification, validation, characterization and support of stability studies for small molecule programs

• Technical proficiency with techniques that include, but are not limited to, HPLC, UPLC, GC, KF, IC, IR, MS, Spectroscopy, UV, and XRPD

• Experience and understanding of analytical chemistry, pharmaceutical development, and phase appropriate control strategies

• Excellent interpersonal skills with strong oral and written communication abilities, including drafting and reviewing technical documents

• Excellent laboratory and productivity skills

• Comprehensive understanding of cGMP requirements in drug substance and drug product

• Expert knowledge of cross-functional understanding related to drug development

• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements

#LI-LS1

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respec

Similar jobs

• Senior Scientist I Analytical Development — Alumis · Remote
• Senior Scientist, Analytical Development, Manager — Catalent · San Diego, CA
• Senior Associate Scientist - Analytical Development — Catalent · Madison, WI
• Senior Associate Scientist - Analytical Development — Elanco · Fort Dodge, IA
• Associate Scientist, Analytical Development — Bristol Myers Squibb · New Brunswick, NJ
• Principal Scientist, Analytical Development — Neurocrine · US CA San Diego
• Senior Scientist, Analytical Sciences — Vardaspace · El Segundo, California, United States
• Senior Scientist, Analytical Development and Quality Control — Nurix · Brisbane, CA