Senior Principal Scientist, Peptide Chemistry / API Development

Neurocrine Biosciences • San Diego, CA

4d

About The Position

Neurocrine Biosciences is seeking a senior scientific leader to lead its peptide chemistry and peptide API development function or a major program area. The role defines scientific strategy and development standards for peptide drug substances from early development through commercialization, combining advanced peptide synthesis and process chemistry expertise with strategic CMC leadership to establish robust, scalable, commercially viable manufacturing approaches.

The position guides cross-functional and external teams, resolves complex technical challenges, and translates scientific and regulatory expectations into development strategies across the peptide portfolio. It leads peptide process development, optimization, scale-up, technology transfer, manufacturing readiness, control-strategy development, technical risk assessment, process characterization, and regulatory CMC support. The role also oversees laboratory activities and resources, manages CDMO and contractor partnerships, drives manufacturing innovation, and mentors peptide chemists and technical leads.

The successful candidate will partner with Analytical Development, Formulation, Quality, Regulatory, Supply Chain, Project Management, Discovery, and other teams, while influencing portfolio-level and external decisions through scientific rationale and strategic communication. The position is based at Neurocrine Biosciences; no specific work location or workplace arrangement is stated.

Requirements

• Bachelor’s degree in chemistry, biochemistry, biology, chemical engineering, or a similar scientific discipline and 10 or more years of relevant experience; or a master’s degree in one of these disciplines and 8 or more years of relevant experience; or a Ph.D. in chemistry, organic chemistry, peptide chemistry, biochemistry, chemical engineering, or a similar discipline (or equivalent) and 6 or more years of relevant experience.
• Substantial hands-on and/or technical leadership experience in peptide synthesis, peptide process development, scale-up, technology transfer, or GMP peptide manufacturing.
• Deep expertise in peptide synthesis, including SPPS and/or LPPS.
• Expertise in peptide cleavage and deprotection, preparative chromatography purification, 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.
• Ability to lead cross-functional development programs and make sound technical decisions under aggressive timelines.
• Substantial scientific mastery in peptide chemistry, process chemistry, and pharmaceutical development.
• Ability to translate regulatory, manufacturing, and business objectives into practical scientific direction and apply multidisciplinary expertise to complex technical challenges.
• Ability to lead and integrate teams across programs and organizational boundaries, mentor scientific talent, and build technical capabilities.
• Excellent written, verbal, analytical, and scientific communication skills.
• Ability to implement long-term functional strategy while managing high-stakes initiatives and competing priorities, influence internal and external stakeholders, and demonstrate organizational-level thinking.

Nice To Haves

• Industry experience in peptide API process development and/or manufacturing is strongly preferred.
• Experience with fragment condensation, hybrid approaches, Tag assist peptide synthesis, or complex modified peptides is highly desirable.
• Experience with bioconjugation, lipidation, PEGylation, or other peptide modification technologies is a plus.

Responsibilities

• Apply advanced scientific principles in peptide and organic chemistry to complex, cross-asset API development challenges.
• Lead teams applying 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 SPPS, LPPS, hybrid or 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 control-strategy development by identifying CQAs, CMAs, 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 scientific standards, safe operations, and efficient execution.
• Lead resolution of technical challenges involving coupling, aggregation, deletion sequences, epimerization, oxidation, cleavage, purification, precipitation, lyophilization, and product stability.
• Drive innovation in peptide manufacturing technologies to improve quality, robustness, sustainability, cycle time, and cost of goods.
• Develop and manage 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 with Analytical Development, Formulation, Quality, Regulatory, Supply Chain, Project Management, Discovery, and other cross-functional teams.
• Coach and mentor peptide chemists and technical leads, building capability and scientific excellence within the function.
• Influence cross-departmental, portfolio-level, and external decisions through clear scientific rationale and strategic communication.
• Strengthen internal and external scientific networks and represent the organization in technical discussions with CDMOs, consultants, and external experts.
• Perform other duties as assigned.

Benefits

• Annual bonus with a target of 30% of earned base salary.
• Eligibility to participate in an equity-based long-term incentive program.
• Retirement savings plan with company match.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree