Director - Dissolution Science & Biopharmaceutics

BioSpace; Indianapolis (IN); On-site; USD 149,000 - 257,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision coverage

Flexible benefits

Life insurance

Well-being programs

Disability accommodation

Job summary

Lilly’s Indianapolis team seeks a senior scientist to lead dissolution biopharmaceutics efforts. This role bridges formulation science, biopharmaceutics, and regulatory strategy, leveraging modeling and in silico tools to support clinical and commercial programs.

You will mentor a small team and contribute to publications, conferences, and cross-functional collaborations to advance dissolution science capabilities.

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 8+ years in drug product development.
• Technical leadership in dissolution, biopharmaceutics, and product performance across development to submission.
• Track record of authoring regulatory dissolution content in CTD Modules (3.2.P.2, 3.2.P.5, 2.7.1).
• Experience applying PBBM to biowaivers, bridging risk, and dissolution justification.
• Knowledge of FDA/EMA CMC regulatory requirements and trends.

Responsibilities

• Develop dissolution methods linking in vitro to in vivo for IR and modified-release forms.
• Lead biopharmaceutics strategy using in vitro/in vivo/in silico tools, including PBBM.
• Author CMC/biopharmaceutics regulatory content for submissions and health authority responses.
• Direct a small team of scientists, mentoring and career development.
• Engage external science via publications and conferences.

Skills

Dissolution science

Biopharmaceutics

PBBM modeling

Regulatory submission support

IVIVC/IVIVR

Education

Ph.D. in Pharmaceutical Sciences

M.S. in related field

B.S. in related field

Tools

GastroPlus

Simcyp

DDDPlus

STELLA

Job description

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: 0 to 10%
• Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC‑N)
• 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).
• Benefits and perks:
• Company-sponsored 401(k) eligibility; pension; vacation benefits; 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; time off and leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
• 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).