Position Overview:

The Senior Scientist, CMC Analytical Lead provides analytical leadership for assigned drug substance and drug product programs from IND-enabling studies through clinical development, registration, and commercial readiness. This role supports phase-appropriate analytical strategy and execution across key CMC activities, including IND-enabling, toxicology, early through late-stage clinical supply, drug substance process development, formulation and drug product development, and manufacturing. Responsibilities include analytical input to method readiness, transfer and validation strategy, release and stability strategy, shelf-life planning, specifications, data interpretation, and regulatory submissions.

This role is part of the CMC Analytical group and works closely with CMC, Quality, Regulatory, Supply Chain, and external CRO/CDMO partners to ensure analytical deliverables are scientifically sound, phase appropriate, and aligned with program needs. It includes hands-on analytical work, including method development and troubleshooting, while the primary focus remains program-level analytical leadership, risk assessment, cross-functional coordination, and oversight of internal and external analytical activities.

As part of a growing CMC Analytical team, this position offers strong opportunity for career advancement, direct impact on development programs, and continued growth into broader analytical program leadership.

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.

Qualifications:

Required Qualifications:

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, ARD, or CMC analytical support across Phase 1 through commercialization; approximately 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 drug substance and/or drug product analytical development, including method readiness, release and stability testing, data interpretation, and phase-appropriate documentation for clinical through registration stages.

Working knowledge of analytical techniques used in pharmaceutical development, such as HPLC/UPLC, dissolution, GC, LC-MS, KF, spectroscopy, solid-state characterization, and compendial methods.

Hands-on experience with analytical method development, troubleshooting, qualification, transfer, or validation in a pharmaceutical development or regulated laboratory setting.

Understanding of phase-appropriate CMC expectations, GMP and non-GMP development environments, quality systems, and regulatory guidance for analytical procedures, validation, impurities, stability, shelf-life, and specifications.

Effective communication, collaboration, organization, and problem-solving skills, with the ability to manage multiple priorities and communicate scientific rationale to technical and cross-functional audiences.

Highly Desirable Qualifications:

Experience representing analytical development on cross-functional CMC program teams supporting IND-enabling activities, toxicology supply, early clinical supply, drug substance process development, formulation or drug product development, or later-stage development.

Experience contributing to analytical control strategy, specification development or justification, stability strategy, shelf-life planning, stability trending, or regulatory submission content.

Experience working with CROs/CDMOs or external testing laboratories, including technical oversight, documentation review, issue resolution, and timeline management.

Specific expertise in product- or process-specific analytical challenges, such as supporting drug substance process development, characterization and qualification efforts, impurity control, stability-indicating method strategy, dissolution, compendial testing, or analytical method development for oral solid dosage and/or injectable products.

This role offers the opportunity to contribute to analytical strategy and execution for innovative drug development programs. The successful candidate will be scientifically curious, collaborative, and able to translate analytical and CMC data into practical, phase-appropriate decisions.

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.