Senior Scientist, Analytical CMC
Eikon TherapeuticsMillbrae, California, United States · Posted 24 days agoDescription
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
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.
About You
You are a scientifically curious, collaborative analytical scientist with experience supporting drug substance and drug product development across the CMC lifecycle. You bring strong technical expertise in analytical method development, troubleshooting, transfer, and validation, along with a solid understanding of phase-appropriate CMC, GMP, and regulatory expectations. You excel at managing multiple priorities, translating scientific data into practical, phase-appropriate decisions, communicating complex scientific concepts to cross-functional teams, and collaborating with cross-functional stakeholders and external CRO/CDMO partners to advance analytical strategies and program deliverables.
What You’ll Do
- 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.
Qualifications
- Ph.D. 5+ years, M.S. 14+ years, or B.S. 16+ years Degree in analytical chemistry, chemistry, pharmaceutical sciences, or a related discipline, including directly relevant experience in analytical development, or CMC analytical support for clinical and/or commercialization stages.
- 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.
- 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.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
- 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
The expected salary range for this role is $154,000 to $185,850 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
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