Principal Scientist, Analytical Development; Biologics

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.

This position will serve as analytical development lead for multiple projects, with a focus on Biologics including monoclonal antibodies, bi‑specific monoclonal antibodies, tri‑specific monoclonal antibodies, and antibody conjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify analytical methods used to control in‑process intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies.

Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.

• Lead analytical method development and validation/qualification activities for Biologics (e.g. monoclonal antibodies, bi‑specific monoclonal antibodies, tri‑specific monoclonal antibodies, and antibody conjugates) within cGMP compliance in support of preclinical through commercialization
• Represent Analytical development on cross‑functional teams
• Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
• Direct laboratory work and/or lab personnel within the company and at external vendors
• Deep technical expertise in separation method development (e.g. SEC‑UPLC, RP‑UPLC, HILIC‑UPLC, IEX‑UPLC, HIC‑UPLC, Mixed Mode‑UPLC, 2D‑LC, CE‑SDS, iCIEF etc.), potency method development (e.g. ELISA, cell‑based bioassay etc.), process related impurities method development (e.g. ELISA, qPCR, LC) for Biologics and extensive knowledge of CQA assessment, analytical comparability, and stability
• Support off‑site analytical method transfers, manufacturing support, and interaction with external vendors
• Provide input into CMC regulatory documentation and supporting work
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC strategies
• Contribute to development of policies and department strategies
• Build and enhance internal and external professional relationships
• Support career development and technical growth of team members
• Present finding at varying levels across the company
• Other duties as assigned

• BS/BA in Analytical Chemistry or related discipline and 8+ years of experience in the analytical/pharmaceutical development field
• Experience in method transfer in Analytical Chemistry OR MS/MA in Analytical Chemistry or related discipline and 6+ years of experience OR PhD in Analytical Chemistry or related discipline and 4+…