Senior Research Director, Analytical Chemistry - ...

OverviewSenior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development.ResponsibilitiesDrive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development.Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions).Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets.Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation).Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions.Welcome varied perspectives to create new solutions.Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio.Basic RequirementsPh.D. in analytical chemistry or bioanalytical chemistry, or a related field8+ years’ experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides.Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities.Must possess strong communication (oral, written), organizational, and leadership skills.Additional PreferencesExperience with product commercialization, including technical transfer of analytical methods into manufacturing operations.Demonstrated ability to drive and accept change.Good interpersonal skills and a sustained tendency for collaboration.Demonstrated success in persuasion, influence, and negotiation.Additional InformationTravel: 0 to 10%Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)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 (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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. #J-18808-Ljbffr

Created: 2025-09-17