Senior Principal Scientist, Peptide Chemistry / API Development

Neurocrine Biosciences•San Diego, CA

19h•$173,600 - $237,000

About The Position

Lead the peptide chemistry and peptide API development function or a major program area, defining scientific strategy and development standards for peptide drug substances from early development through commercialization. The 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 guides cross-functional and external teams, resolves complex technical challenges, and translates evolving scientific and regulatory expectations into clear development strategies across the peptide portfolio.

Requirements

A BS/BA in chemistry, biochemistry, biology, chemical engineering, or a similar scientific discipline and 10+ years of relevant experience; or an MS/MA in one of these disciplines and 8+ years; or a PhD in chemistry, organic chemistry, peptide chemistry, biochemistry, chemical engineering, or a similar scientific discipline (or equivalent) and 6+ years.
Relevant experience that includes 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/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.
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.
Significant contribution to functional scientific strategy and portfolio-level peptide development decisions.
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 and development challenges.
Ability to lead and integrate teams across programs and organizational boundaries, mentor scientific talent, and build strong 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 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 and 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 high scientific standards, safe operations, and efficient execution.
Lead resolution of 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 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.
Strengthen internal and external scientific networks and represent the organization in technical discussions with CDMOs, consultants, and external experts.
Perform other duties as assigned.