Director - Dissolution Science & Biopharmaceutics

Eli Lilly and Company • Us, IN

5d • 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 preclinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, antibody-drug conjugates (ADCs) and other emerging therapeutic modalities. SMDD fosters a culturally diverse, high-performing workforce with deep technical expertise across these platforms. This is a technical leadership role that combines laboratory and modeling work with strategic influence across the product development lifecycle. You will have access to Lilly's world-class dissolution, biopharmaceutics modeling (PBBM), and analytical capabilities at the Lilly Technology Center in Indianapolis. SMDD is seeking a Director / Senior Director / Executive Director to lead the dissolution science and biopharmaceutics function for small molecule drug products, from early-phase development through commercialization. In this role, you will lead the product performance strategy on multidisciplinary project teams — developing and justifying dissolution methods, building biopharmaceutics risk assessments and biowaiver strategies, authoring CMC and biopharmaceutics regulatory content for global submissions and responses to health authority questions. In addition, you will drive the innovation agenda and contribute to Lilly’s external scientific presence in this area. The role includes management of a small team of 1–5 scientists and direct responsibility for multiple projects as well as technical oversight across a broader portfolio. You will work in close partnership with formulation, analytical, engineering, ADME, clinical pharmacology, and regulatory colleagues across Lilly Research Labs.

Requirements

• Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, Chemical Engineering, or related discipline with 8+ years of pharmaceutical industry experience in drug product development and commercialization. (Will also consider M.S. with 12+ years or B.S. with 15+ years of directly relevant experience.)
• Technical leadership experience in dissolution science, biopharmaceutics, and product performance for small molecule drug products, with demonstrated ownership of deliverables from early development through regulatory submission, including hands-on experience with biorelevant dissolution testing, discriminating method development, and dissolution method lifecycle management across clinical and commercial phases.
• Track record of authoring CMC and biopharmaceutics regulatory sections (dissolution-related content in CTD Modules 3.2.P.2, 3.2.P.5, 2.7.1) and responding to health authority questions on product performance topics.
• Demonstrated experience applying PBBM to biowaivers, bridging risk assessments, clinically relevant dissolution method justification, or specification setting.
• Demonstrated knowledge of applicable CMC regulatory requirements (FDA, EMA, and other major health authorities) and emerging regulatory trends in dissolution and biopharmaceutics.

Nice To Haves

• Strong publication record and external scientific engagement in dissolution science, biopharmaceutics, or related fields.
• Proficiency with one or more biopharmaceutics modeling platforms (e.g., GastroPlus, Simcyp, DDDPlus, STELLA) and experience establishing IVIVC/IVIVR or bioequivalence safe spaces.
• Knowledge of formulation development and physical pharmacy of small molecules, including poorly soluble compounds and enabling formulation technologies (e.g., amorphous solid dispersions, spray-dried intermediates).
• Demonstrated ability to influence cross-functional alignment and negotiate technical decisions across formulation, analytical, engineering, ADME, clinical pharmacology, and regulatory functions.
• Experience mentoring and developing technical talent at the scientist and senior scientist level.

Responsibilities

• Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug product performance to in vivo behavior, spanning immediate-release and modified-release oral solid dosage forms.
• Apply conventional and biorelevant/predictive dissolution as well as novel approaches to assess oral performance of drug molecules and formulations in humans.
• Build and execute biopharmaceutics strategies using in vitro, in vivo, and in silico tools — including physiologically based biopharmaceutics modeling (PBBM) — to assess oral absorption, predict bridging risk, and establish clinically relevant specifications.
• Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR dossiers.
• Partner with formulation scientists, analytical chemists, engineers, clinical pharmacologists, and regulatory colleagues to define product performance control strategies — including specifications, dissolution method lifecycle management, and post-approval change strategies.
• Support the design of new dosage forms and drug delivery technologies by applying pharmaceutical sciences knowledge spanning formulation, biopharmaceutics, pharmacokinetics, and patient-centered drug product design.
• Plan and lead short-term and long-term dissolution and biopharmaceutics development activities across assigned programs and broader portfolio.
• Develop technical agendas and timelines, recommend resource allocation, communicate progress, and propose changes in direction when warranted.
• Directly lead a small team (1–5 scientists), providing technical mentorship, career development, and performance coaching.
• Influence and engage the external scientific community through publications, conference presentations, and collaborations that advance Lilly’s dissolution science and biopharmaceutics capabilities.
• Evaluate and integrate emerging science from adjacent disciplines (e.g., formulation science, PAT, modeling and simulation) into dissolution and biopharmaceutics practice.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• 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: Director
• Education Level: Ph.D. or professional degree