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San Diego, California, United States
Onsite
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)
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Apply highly advanced scientific principles in peptide and organic chemistry to complex, cross-asset API development challenges
Lead 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 development
Lead 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 isolation
Drive scale-up, process transfer, and manufacturing readiness from laboratory scale through clinical, registration, PPQ, and commercial manufacturing
Guide 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 controls
Lead technical risk assessments, process characterization, robustness studies, and investigations for complex peptide manufacturing processes
Oversee laboratory activities and resource allocation while ensuring high scientific standards, safe operations, and efficient execution
Lead resolution of high-impact technical challenges related to coupling, aggregation, deletion sequences, epimerization, oxidation, cleavage, purification, precipitation, lyophilization, and product stability
Drive innovation in peptide manufacturing technologies to improve product quality, process robustness, sustainability, cycle time, and cost of goods
Develop and manage strategic CDMO and contractor partnerships, including technical evaluation, vendor selection, technology transfer, person-in-plant support, and manufacturing oversight
Provide technical leadership for CMC regulatory documentation and readiness, including development reports, process descriptions, control strategies, regulatory starting-material justification, and responses to health-authority questions
Partner effectively with Analytical Development, Formulation, Quality, Regulatory, Supply Chain, Project Management, Discovery, and other cross-functional teams
Provide leadership, coaching, and scientific mentoring to peptide chemists and technical leads; build capability and scientific excellence within the function
Influence cross-departmental, portfolio-level, and external decisions through clear scientific rationale and strategic communication
Strengthening internal and external scientific networks and representing the organization in technical discussions with CDMOs, consultants, and external experts
Performs other duties as assigned
BS/BA in chemistry, biochemistry, biology, chemical engineering, or similar scientific discipline and 10+ years of relevant experience; OR
MS/MA in chemistry, biochemistry, biology, chemical engineering, or similar scientific discipline and 8+ years of relevant experience; OR
PhD in chemistry, organic chemistry, peptide chemistry, biochemistry, chemical engineering, or similar scientific discipline (or equivalent) and 6+ years of relevant experience
Relevant experience should include substantial hands-on and/or technical leadership experience in peptide synthesis, peptide process development, scale-up, technology transfer, or GMP peptide manufacturing
Industry experience in peptide API process development and/or manufacturing is strongly preferred for this role
Deep 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 desirable
Expertise in peptide cleavage/deprotection, purification by preparative chromatography, and product isolation by precipitation and/or lyophilization
Strong understanding of peptide-related impurities and degradation pathways, including deletion sequences, epimerization, oxidation, deamidation, aggregation, and sequence-dependent challenges
Proven experience in process development, scale-up, technology transfer, and manufacturing of peptide drug substances
Demonstrated knowledge of process characterization, validation, control strategy development, and lifecycle management
Advanced understanding of cGMP, ICH expectations, CMC regulatory requirements, and regulatory starting-material strategy as applied to peptide APIs
Experience overseeing GMP manufacturing and person-in-plant activities at external manufacturing sites
Experience with bioconjugation, lipidation, PEGylation, or other peptide modification technologies is a plus
Ability to lead cross-functional development programs and make sound technical decisions under aggressive timelines
Significant contributor to functional scientific strategy and portfolio-level peptide development decisions
Substantial scientific mastery in peptide chemistry, process chemistry, and pharmaceutical development
Translates regulatory, manufacturing, and business objectives into practical scientific direction
Applies multidisciplinary expertise to complex technical and development challenges
Leads and integrates teams across programs and organizational boundaries
Mentoring scientific talent across levels and builds strong technical capabilities
Excellent written, verbal, analytical, and scientific communication skills
Implements long-term functional strategy while managing high-stakes initiatives and competing priorities
Influences internal and external stakeholders and demonstrates organizational-level thinking
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Neurocrine 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.
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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.