Senior Director, Analytical Development CMC

BioSpace; Indianapolis (IN); On-site; USD 153,000 - 290,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Pension

Paid time off

Job summary

Lilly, headquartered in Indianapolis, seeks a Senior Director of Analytical Development to lead phase‑appropriate method development and product characterization across multiple programs. You will drive strategy, manage external CDMO collaborations, and ensure data integrity for regulatory filings while mentoring junior staff.

The role emphasizes strong cGMP knowledge, cross‑functional collaboration, and global regulatory awareness in a fast‑paced environment. Based in the US with some travel.

Qualifications

• Advanced degree in chemistry or pharmaceutical sciences (PhD preferred).
• 10+ years in small molecule pharmaceutical industry.
• Experience in early phase analytical development and cGMP regulatory requirements.

Responsibilities

• Lead analytical strategy across phase-appropriate method development and product characterization.
• Oversee third‑party vendor work (CDMOs) for method transfer, qualification, validation, and stability testing.
• Review validation data and test results for release, stability, and characterization.
• Coordinate documentation and data packages for regulatory submissions (IND, NDA, etc).
• Collaborate with Quality on investigations and OOE/OOT/OOS events.
• Mentor junior analytical scientists and represent CMC in cross‑functional teams.
• Drive regulatory filings support including justifications and dissolution method development.

Skills

Analytical development

cGMP knowledge

Regulatory familiarity

Project management

Leadership

Education

PhD in chemistry

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—and it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

Centessa’sCMC groupis seekingaSenior Director of Analytical Developmentwithin the CMC group. The successful candidate will have hands‑on experience in the development and validation of raw material, in‑process, small molecule drug substance, and solid oral dose drug product methods at all stages of development.

Reporting to the Executive Director, this rolewill drive analytical method gap assessments, method development, and strategy at various CDMOs and liaise cross‑functionally with drug substance and drug product teams across programs. Comprehensive working knowledge of cGMP and Regulatory guidance as they relate to regulatory starting material, drug substance and drug product development, characterization, release, and stability testing of small molecules is paramount.

This position will be accountable for all analytical CMC data from external CDMOs to meet company deliverables and timelines. Travel to vendors both domestically and internationally will be required.

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 primarily 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, discriminatory and quality control dissolution method development, and structural elucidations
• Review and drafting of internal technical reports and information for analytical sections in global submission documents and modules (e.g. IND, IMPD, NDA, MAA, etc) as well as responses to Regulatory requests for information
• Work cross‑functionally with Quality as a technical expert to aid in analytical OOE/OOT/OOS investigations, deviations, and other troubleshooting
• Active participation in batch record review

Minimum 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 (e.g., genotoxic, nitrosamines), 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 (real‑time, accelerated, and forced degradation)
• Strong understanding of product quality attributes and control strategies for small molecule synthetic processes
• Demonstrated leadership in coordinating analytical and broader CMC activities supporting development and commercialization
• Excellent project management, organizational, and prioritization skills in fast‑paced, multi‑project environments
• Strong analytical planning, resource management, and budget oversight skills across global CDMO networks
• Effective decision‑maker and communicator, able to work independently while collaborating across functions and organizational levels

Work Location:

• The Senior Director, Analytical Development role is based in the US, with occasional travel.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace‑accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$153,000 - $290,400

Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for 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; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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