Director - Dissolution Science & Biopharmaceutics

Director - Dissolution Science & Biopharmaceutics Eli Lilly - 4.1 Indianapolis, IN Job Details Full-time $148,500 - $257,400 a year 16 hours ago Benefits Health insurance Dental insurance 401(k) Flexible spending account Employee assistance program Career development plan Vision insurance Life insurance Qualifications FDA submissions Product lifecycle strategy Developing new product formulations Clinical development Investigational new drug (IND) applications Pharmaceutical company experience Content development Chemistry, manufacturing & controls Regulatory submission editing and review Communication with regulatory authorities for clinical trials Chemical new product development projects Pharmaceutical research Risk assessment implementation Senior leadership Full 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—but 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. 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. Responsibilities Core Technical Scope 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. Strategic and Cross-Functional Leadership 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. People Leadership and External Engagement 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. Basic Qualifications 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. Additional Skills/Preferences 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.

Additional Information Travel:

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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 (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 $148,500 - $257,400 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. #WeAreLilly