Senior Director, Analytical Development (CMC) – Molecule

Eli Lilly and Company; Indianapolis (IN); On-site; USD 174,000 - 290,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Pension plan

Vacation benefits

Medical, dental, vision benefits

Flexible benefits (FSA)

Job summary

Eli Lilly and Company in Indianapolis is seeking a Senior Director of Analytical Development to lead method development, validation, and product characterization across programs, including third‑party CDMOs. You will drive analytical strategy and regulatory readiness.

The role requires an advanced degree in chemistry or pharmaceutical sciences and 10+ years in small molecule analytics, with GMP expertise, leadership, and cross‑functional collaboration across global teams.

Qualifications

• Advanced degree in chemistry, pharmaceutical sciences, or related field (PhD strongly preferred).
• 10+ years of small molecule pharmaceutical industry experience.
• Extensive experience in early phase analytical development of small molecule oral solid dosage forms.
• Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products.
• Strong technical background in chemical and physical characterization, including polymorphism, particle size, residual solvents, process impurities, and forced degradation mechanisms.
• Significant experience in analytical method development and GMP qualification/validation, including assay, related substances, and dissolution.
• Proven ability to manage and direct outsourced analytical activities, including assay development, stability, and quality control at CDMOs.
• Hands‑on experience designing, managing, and interpreting stability programs.

Responsibilities

• Lead analytical strategy related to phase‑appropriate method development, validation, and product characterization for multiple programs.
• Collaboratively work in a team environment to lead drug substance and drug product analytical development activities at third‑party vendors including method implementation, qualification/validation, and transfer in support of pre‑IND through Registrational programs.
• Review method validation protocol and reports, and test data for release, stability, and characterization.
• Save and store documentation, generate stability result tables, file stability data for expiry and shelf‑life assignments.
• Lead specification settings based upon batch history and supporting analytical data.
• Act as the CMC team analytical representative member in program development teams.
• Act as role model and subject matter expert for junior analytical scientists.
• Significantly contribute to CMC analytical aspects of regulatory filings including regulatory starting material justifications, justification of specifications, and dissolution method development.
• Review and drafting of internal technical reports and information for analytical sections in global submission documents and modules (e.g. IND, IMPD, NDA, MAA).
• Work cross‑functionally with Quality as a technical expert to aid in analytical investigations, deviations, and troubleshooting.
• Active participation in batch record review.

Skills

Analytical development

cGMP knowledge

Regulatory strategy

Leadership

Cross‑functional collaboration

Outsourcing management

Quality control

Stability program design

Budget oversight

Communication

Education

PhD in chemistry or pharmaceutical sciences

Tools

CDMO management

Job description

Eli Lilly and Company in Indianapolis is seeking a Senior Director of Analytical Development to lead method development, validation, and product characterization across programs, including third‑party CDMOs. You will drive analytical strategy and regulatory readiness.

The role requires an advanced degree in chemistry or pharmaceutical sciences and 10+ years in small molecule analytics, with GMP expertise, leadership, and cross‑functional collaboration across global teams.