Principal Scientist, Analytical Development

Neurocrine Biosciences

114d • $128,200 - $185,900

About The Position

Neurocrine Biosciences is seeking a highly motivated and experienced Principal Scientist, Analytical Development, to support small-molecule pharmaceutical development within our CMC team. The successful candidate will independently lead multiple analytical projects 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 15+ years of relevant pharmaceutical R&D or QC experience
• MS/MA in Analytical Chemistry with 10+ years of relevant industry experience
• Ph.D. in Analytical Chemistry with 8+ 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 including medical, prescription drug, dental and vision coverage
• Annual bonus with a target of 30% of the earned base salary
• Eligibility to participate in equity based long term incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees