Senior Research Advisor / Research Advisor, Analytical Chemistry – TIDES, SMDD

Lilly • Indianapolis, IN

6d • $126,000 - $204,600 • Onsite

About The Position

The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.
The Senior Research Advisor / Research Advisor, Analytical Chemistry – TIDES, will serve as the analytical lead for early-phase synthetic peptide and oligonucleotide (TIDES) programs, from pre-clinical enabling studies through first-in-human clinical supply. This is an externally focused role: the successful candidate will provide the analytical leadership that enables GLP and GMP campaigns executed at contract manufacturing and testing organizations, and will translate that work into the control strategies and IND documentation that support Phase 1 entry. Working within a multidisciplinary team of chemists, formulation scientists, and engineers, and partnering closely with Quality and Regulatory CMC, this individual will own the analytical package for their molecules while accessing world-class internal capabilities for peptide and oligonucleotide characterization.

Requirements

• Ph.D. in analytical chemistry or bioanalytical chemistry, or a closely related scientific discipline with 2+ years of relevant industry experience; or M.S. with 5+ years; or B.S. with 7+ years of pharmaceutical or biotechnology industry experience in analytical development.
• Demonstrated experience in analytical method development, qualification or validation, and transfer for peptides, oligonucleotides, or small molecules.
• Deep working knowledge of chromatographic separations (e.g., reversed-phase, size exclusion, ion exchange) and mass spectrometry, with a general understanding of other techniques used for synthetic molecules (e.g., UV, GC, KF, ICP, NMR).
• Understanding of method performance attributes (e.g., specificity, linearity, precision, accuracy, LOD/LOQ) and the ability to set fit-for-purpose expectations for early-phase work.
• Experience in a GMP environment and familiarity with applicable ICH and compendial (USP/Ph. Eur.) requirements.
• Strong written and verbal communication skills, including technical documentation for cross-functional and external audiences.

Nice To Haves

• Direct experience with solid-phase peptide synthesis (SPPS) and/or oligonucleotide synthesis and the characterization of the associated process-related impurities.
• Experience authoring or contributing to regulatory CMC documentation (e.g., IND/CTA, NDA/MAA) for peptides or oligonucleotides.
• Demonstrated experience overseeing CMO/CRO analytical activities, including campaign support and technical governance of external testing.
• Familiarity with GLP expectations for test article characterization and with first-in-human parenteral drug product testing.
• Demonstrated scientific leadership, the ability to influence without direct authority, and comfort prioritizing across programs in ambiguity.

Responsibilities

• Serve as the analytical lead for early-phase TIDES molecules, owning the phase-appropriate control strategy for drug substance and drug product.
• Provide technical direction and oversight to CMO and CRO partners: define analytical deliverables, approve method development and qualification protocols and reports, oversee method transfer and verification, assess external data packages, and drive resolution of OOS/OOT results and analytical investigations.
• Oversee the analytical elements of GLP and GMP campaigns, including readiness assessment, release and in-process testing, reference standard qualification, batch data review, and support of drug substance and drug product disposition with Quality.
• Author and review CMC sections of INDs and CTAs — analytical procedures, validation summaries, specification justification, batch analyses, impurity and stability sections — and support responses to health authority questions.
• Establish and justify phase-appropriate specifications and stability programs, addressing related substances and process-related impurities, residual solvents and reagents (ICH Q3C, M7), elemental impurities, water and counterion, potency, and microbiological quality and endotoxin.
• Collaborate with chemists, formulation scientists, engineers, Quality, and Regulatory CMC to integrate analytical strategy with program plans, managing multiple concurrent molecules.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

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