Senior Scientist, Analytical CMC

Eikon Therapeutics • Millbrae, CA

13h

About The Position

The Senior Scientist, CMC Analytical Lead provides analytical leadership for drug substance and drug product programs from IND-enabling studies through clinical development, registration, and commercial readiness. This role leads phase-appropriate analytical strategy across CMC activities, partnering closely with CMC, Quality, Regulatory, Supply Chain, and external CRO/CDMO organizations to ensure high-quality analytical deliverables that support program milestones and regulatory submissions. While the position includes hands-on analytical support, its primary focus is providing program-level leadership, cross-functional coordination, risk assessment, and oversight of analytical development activities. As part of a growing CMC Analytical team, this role offers the opportunity to make a meaningful impact on development programs while advancing into broader analytical leadership.

Requirements

• Degree in analytical chemistry, chemistry, pharmaceutical sciences, or a related discipline, with typical overall experience of Ph.D. 5+ years, M.S. 14+ years, or B.S. 16+ years, including directly relevant experience in analytical development, or CMC analytical support for clinical and/or commercialization stages; 5–6+ years of directly relevant experience is expected for M.S.-level candidates and 10+ years for B.S.-level candidates. Equivalent combinations of education and relevant experience may be considered.
• Experience supporting DS and/or DP analytical development from clinical through registration.
• Working knowledge of key analytical techniques, including HPLC/UPLC, dissolution, GC, LC-MS, KF, spectroscopy, solid-state, and compendial methods.
• Hands-on experience with method development, troubleshooting, qualification, transfer, and/or validation in pharmaceutical or regulated lab settings.
• Understanding of phase-appropriate CMC, GMP/non-GMP, quality, and regulatory expectations for methods, validation, impurities, stability, shelf-life, and specifications.
• Strong communication, collaboration, organization, and problem-solving skills, with ability to manage priorities and explain scientific rationale clearly.

Nice To Haves

• Experience representing analytical development on cross-functional CMC teams from IND-enabling through later-stage development highly preferred.
• Experience with analytical control strategy, specifications, stability, shelf-life, trending, or regulatory submission content highly preferred.
• Experience overseeing CRO/CDMO or external lab activities highly preferred.
• Expertise in impurity control, stability-indicating methods, dissolution, compendial testing, or DS/DP method development highly preferred.

Responsibilities

• Serve as the CMC Analytical Lead for assigned drug substance and drug product programs, coordinating analytical activities, tracking deliverables, communicating risks, and supporting program milestones in collaboration with senior technical and cross-functional stakeholders.
• Support analytical method development, troubleshooting, qualification, transfer, and validation for drug substance, intermediates, raw materials and drug product, as appropriate for the stage of development.
• Provide hands-on or laboratory-facing analytical support for non-GMP sample analysis for creation of CoA, method development, troubleshooting, investigation support, data interpretation, and resolution of technical issues during development, transfer, validation, release, or stability testing.
• Provide scientific oversight of CRO/CDMO analytical activities, including review of methods, protocols, reports, deviations, investigations, data summaries, and timelines to ensure quality, scientific soundness, and phase-appropriate execution.
• Contribute to phase-appropriate analytical control strategies, including specifications, method readiness, reference standards, impurity control, stability strategy, shelf-life planning and stability trending, and justification of analytical approaches with guidance from senior CMC, Quality, Regulatory, and program stakeholders as appropriate.
• Collaborate with Research, Drug Substance, Drug Product, Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain, and Clinical Operations to ensure analytical deliverables support development, clinical supply, regulatory filings, and program decision-making.
• Author, review, and contribute to analytical technical documents and regulatory submission content, including development reports, qualification or validation protocols and reports, specifications, stability summaries, shelf-life assessments, INDs, IMPDs, NDAs, and responses to regulatory questions.
• Proactively identify analytical risks, propose mitigation strategies, communicate recommendations clearly, and provide technical guidance to junior staff or external collaborators as appropriate.

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%)
• dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

What This Job Offers

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