Sr. Scientist, Analytical Chemistry, CMC

Neurocrine Biosciences Inc.•San Diego, CA

52d

About The Position

Neurocrine Biosciences is seeking a highly motivated and experienced Sr. Scientist, Analytical Development, to support small-molecule pharmaceutical development Chemical Development within our CMC team. The successful candidate will lead multiple analytical projects with minimal supervision and perform laboratory experiments to support both early- and late-stage programs. This role involves close collaboration with global Contract Manufacturing Organizations (CMOs) to ensure the development, transfer, and validation of analytical methods for regulatory starting materials, intermediates, and active pharmaceutical ingredients (APIs). Key responsibilities include method development and validation, troubleshooting out-of-specification (OOS) and out-of-trend (OOT) results, contributing to regulatory submissions, and ensuring analytical readiness in a fast-paced environment. Proficiency in HPLC, mass spectrometry (MS), and Headspace GC is essential. The ideal candidate is a technically strong leader, an effective communicator, and a collaborative team player who thrives in a dynamic, well-equipped laboratory setting.

Requirements

BS/BA in Analytical Chemistry or related field with 10+ years of relevant pharmaceutical R&D or QC experience
MS/MA in Analytical Chemistry with 8+ years of relevant industry experience
Ph.D. in Analytical Chemistry with 5+ years of relevant industry experience
Strong hands-on experience with HPLC and related troubleshooting
Practical knowledge of MS, GC, and other analytical instrumentation
Understanding of cGMP standards and regulatory requirements for analytical method development and documentation
Proficiency in data acquisition and analysis software, as well as Microsoft Office applications
Demonstrated ability to analyze and interpret complex data sets and draw scientifically sound conclusions
Solid foundation in analytical chemistry principles and laboratory practices
Excellent attention to detail, organizational skills, and ability to manage multiple priorities
Strong written and verbal communication skills, with the ability to work independently and in collaborative teams
Experience authoring and contributing to regulatory filings such as INDs, NDAs, IMPDs, and CTAs
Familiarity working with international CMOs and external testing labs
Project management experience and a proactive, problem-solving mindset

Responsibilities

Develop and execute analytical methods using a range of techniques including HPLC/UPLC, HRMS, GC, HS-GC, MS, IC, NMR, TGA, DSC, PXRD, PSD, KF, and FTIR for drug substances, intermediates, raw materials, and developmental compounds
Lead analytical method development, validation, and troubleshooting under minimal supervision
Conduct and document investigations related to OOS, OOT, or anomalous results
Author analytical sections of regulatory submissions (e.g., NDA, IND, IMPD, CTA) in alignment with global regulatory guidelines and internal quality standards
Perform in-silico assessments for potential mutagenicity and Nitrosamine CPCA risk, following current regulatory guidance
Provide technical leadership and mentorship to junior scientists to foster scientific growth and ensure high-quality output
Collaborate cross-functionally with chemical and formulation development teams to design and execute analytical studies
Ensure compliance with SOPs, data integrity policies, and regulatory requirements through meticulous documentation and recordkeeping
Review and approve internally generated and externally sourced analytical data
Plan and execute in-house stability studies for APIs, intermediates, and prototype drug products
Coordinate instrument maintenance and service; perform routine upkeep as trained
Support laboratory operations, including inventory control and glassware management
Actively contribute to a culture of continuous improvement, scientific excellence, and operational efficiency
Perform 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 in accordance with the terms and conditions of the applicable plans
annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program

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