Principal Scientist, Analytical Development
- San Diego, CA
- $128,200-185,900 per year
- Permanent
- Full-time
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._Your Contributions (include, but are not limited to):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 compoundsLead analytical method development, validation, and troubleshooting under minimal supervisionConduct and document investigations related to OOS, OOT, or anomalous resultsAuthor analytical sections of regulatory submissions (e.g., NDA, IND, IMPD, CTA) in alignment with global regulatory guidelines and internal quality standardsPerform in-silico assessments for potential mutagenicity and Nitrosamine CPCA risk, following current regulatory guidanceProvide technical leadership and mentorship to junior scientists to foster scientific growth and ensure high-quality outputCollaborate cross-functionally with chemical and formulation development teams to design and execute analytical studiesEnsure compliance with SOPs, data integrity policies, and regulatory requirements through meticulous documentation and recordkeepingReview and approve internally generated and externally sourced analytical dataPlan and execute in-house stability studies for APIs, intermediates, and prototype drug productsCoordinate instrument maintenance and service; perform routine upkeep as trainedSupport laboratory operations, including inventory control and glassware managementActively contribute to a culture of continuous improvement, scientific excellence, and operational efficiencyPerform other duties as assignedRequirements:BS/BA in Analytical Chemistry or related field with 15+ years of relevant pharmaceutical R&D or QC experienceMS/MA in Analytical Chemistry with 10+ years of relevant industry experiencePh.D. in Analytical Chemistry with 8+ years of relevant industry experienceStrong hands-on experience with HPLC and related troubleshootingPractical knowledge of MS, GC, and other analytical instrumentationUnderstanding of cGMP standards and regulatory requirements for analytical method development and documentationProficiency in data acquisition and analysis software, as well as Microsoft Office applicationsDemonstrated ability to analyze and interpret complex data sets and draw scientifically sound conclusionsSolid foundation in analytical chemistry principles and laboratory practicesExcellent attention to detail, organizational skills, and ability to manage multiple prioritiesStrong written and verbal communication skills, with the ability to work independently and in collaborative teamsExperience authoring and contributing to regulatory filings such as INDs, NDAs, IMPDs, and CTAsFamiliarity working with international CMOs and external testing labsProject management experience and a proactive, problem-solving mindset#LI-OB1Neurocrine Biosciences is an EEO/Disability/Vets employer.We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description._ The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.