Senior Principal Scientist, Peptide Chemistry / API Development

Biopharma Careers

San Diego (CA)

On-site

USD 174,000 - 237,000

Full time

3 days ago
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Job summary

Neurocrine Biosciences Inc. in San Diego is seeking a Senior Principal Scientist, Peptide Chemistry / API Development to lead the peptide drug-substance strategy from early development through commercialization.

You will guide cross-functional teams, optimize SPPS/LPPS, drive scalable manufacturing, and ensure regulatory readiness. The ideal candidate has a PhD or 8+ years of relevant experience, deep peptide synthesis expertise, and a proven track record in GMP development, tech transfer, and

Qualifications

  • Advanced degree with 6+ years of peptide API development or GMP experience.
  • Expertise in peptide synthesis, SPPS/LPPS, and purification.
  • Strong understanding of CQAs/CMAs/CPPs and regulatory expectations.
  • Experience with technology transfer and external manufacturing partnerships.
  • Leadership of cross-functional development programs under tight timelines.

Responsibilities

  • Lead peptide synthesis and API development strategy across programs.
  • Define governance, technical standards, and lifecycle management for peptide APIs.
  • Oversee scale-up, tech transfer, and manufacturing readiness from lab to commercial.
  • Drive process control strategies and regulatory documentation readiness.
  • Mentor scientists and collaborate with CDMO partners and regulators.

Skills

Peptide synthesis
Process development
Scale-up
Technology transfer
cGMP
Regulatory readiness
Cross-functional leadership
Analytical understanding of CQAs/CMAs
Risk assessment
Project leadership

Education

PhD in chemistry/peptide chemistry/biochemistry/chemical engineering
MS/MA in chemistry/biochemistry/biological engineering
BS/BA in chemistry/biochemistry/biology/chemical engineering

Tools

SPPS
LPPS
Preparative chromatography
Lyophilization
Analytical characterization

Job description

Neurocrine Biosciences Inc.Posted October 24, 2026# Senior Principal Scientist, Peptide Chemistry / API DevelopmentUS CA San Diego, United States Full timeDrug Discovery & Preclinical Research PrincipalNotify me about similar jobsView Full Job & Apply at Neurocrine Biosciences Inc.Neurocrine Biosciences Inc. is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityWho 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. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( \\*in collaboration with AbbVie )About the Role:Lead the peptide chemistry and peptide API development function or major program area, defining scientific strategy and development standards for peptide drug substances from early development through commercialization. This role combines deep expertise in peptide synthesis and process chemistry with strategic CMC leadership to establish robust, scalable, and commercially viable manufacturing approaches. The successful candidate will guide cross-functional and external teams, resolve complex technical challenges, and translate evolving scientific and regulatory expectations into clear development strategies across the peptide portfolio. \\_Your Contributions (include, but are not limited to):Apply highly advanced scientific principles in peptide and organic chemistry to complex, cross-asset API development challengesLead teams in applying advanced peptide chemistry and process-development principles across multiple development programs.Define scientific strategy, governance frameworks, and technical decision standards for peptide API developmentLead development and optimization of peptide manufacturing processes, including solid-phase peptide synthesis (SPPS), liquid-phase peptide synthesis (LPPS), hybrid/fragment approaches, cleavage and deprotection, purification, and drug-substance isolationDrive scale-up, process transfer, and manufacturing readiness from laboratory scale through clinical, registration, PPQ, and commercial manufacturingGuide development of robust control strategies by identifying critical quality attributes (CQAs), critical material attributes (CMAs), critical process parameters (CPPs), proven acceptable ranges, and appropriate in-process controlsLead technical risk assessments, process characterization, robustness studies, and investigations for complex peptide manufacturing processesOversee laboratory activities and resource allocation while ensuring high scientific standards, safe operations, and efficient executionLead resolution of high-impact technical challenges related to coupling, aggregation, deletion sequences, epimerization, oxidation, cleavage, purification, precipitation, lyophilization, and product stabilityDrive innovation in peptide manufacturing technologies to improve product quality, process robustness, sustainability, cycle time, and cost of goodsDevelop and manage strategic CDMO and contractor partnerships, including technical evaluation, vendor selection, technology transfer, person-in-plant support, and manufacturing oversightProvide technical leadership for CMC regulatory documentation and readiness, including development reports, process descriptions, control strategies, regulatory starting-material justification, and responses to health-authority questionsPartner effectively with Analytical Development, Formulation, Quality, Regulatory, Supply Chain, Project Management, Discovery, and other cross-functional teamsProvide leadership, coaching, and scientific mentoring to peptide chemists and technical leads; build capability and scientific excellence within the functionInfluence cross-departmental, portfolio-level, and external decisions through clear scientific rationale and strategic communicationStrengthening internal and external scientific networks and representing the organization in technical discussions with CDMOs, consultants, and external expertsPerforms other duties as assignedRequirements:BS/BA in chemistry, biochemistry, biology, chemical engineering, or similar scientific discipline and 10+ years of relevant experience; ORMS/MA in chemistry, biochemistry, biology, chemical engineering, or similar scientific discipline and 8+ years of relevant experience; ORPhD in chemistry, organic chemistry, peptide chemistry, biochemistry, chemical engineering, or similar scientific discipline (or equivalent) and 6+ years of relevant experienceRelevant experience should include substantial hands-on and/or technical leadership experience in peptide synthesis, peptide process development, scale-up, technology transfer, or GMP peptide manufacturingIndustry experience in peptide API process development and/or manufacturing is strongly preferred for this roleDeep expertise in peptide synthesis, including SPPS and/or LPPS; experience with fragment condensation, hybrid approaches, Tag assist peptide synthesis or complex modified peptides is highly desirableExpertise in peptide cleavage/deprotection, purification by preparative chromatography, and product isolation by precipitation and/or lyophilizationStrong understanding of peptide-related impurities and degradation pathways, including deletion sequences, epimerization, oxidation, deamidation, aggregation, and sequence-dependent challengesProven experience in process development, scale-up, technology transfer, and manufacturing of peptide drug substancesDemonstrated knowledge of process characterization, validation, control strategy development, and lifecycle managementAdvanced understanding of cGMP, ICH expectations, CMC regulatory requirements, and regulatory starting-material strategy as applied to peptide APIsExperience overseeing GMP manufacturing and person-in-plant activities at external manufacturing sitesExperience with bioconjugation, lipidation, PEGylation, or other peptide modification technologies is a plusAbility to lead cross-functional development programs and make sound technical decisions under aggressive timelinesSignificant contributor to functional scientific strategy and portfolio-level peptide development decisionsSubstantial scientific mastery in peptide chemistry, process chemistry, and pharmaceutical developmentTranslates regulatory, manufacturing, and business objectives into practical scientific directionApplies multidisciplinary expertise to complex technical and development challengesLeads and integrates teams across programs and organizational boundariesMentoring scientific talent across levels and builds strong technical capabilitiesExcellent written, verbal, analytical, and scientific communication skillsImplements long-term functional strategy while managing high-stakes initiatives and competing prioritiesInfluences internal and external stakeholders and demonstrates organizational-level thinking#LI-DM1Neurocrine 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 $173,600.00-$237,000.00. 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.
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