Eli Lilly

Advisor Dissolution Science & Biopharmaceutics - SMDD

Eli Lilly • $126K — $204K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, or Chemical Engineering with 0-5 years of relevant experience, or
  • M.S. with 5+ years of relevant experience, or
  • B.S. with 8+ years of relevant experience in dissolution method development and/or biopharmaceutics.
  • Proficient in physicochemical characterization techniques relevant to oral drug product performance, such as dissolution and solubility.
  • Strong background in regulatory expectations for dissolution methods and worldwide marketing authorizations.

Responsibilities

  • Develop and optimize dissolution methods for oral solid dosage forms that detect changes in critical quality attributes.
  • Justify proposed methods through systematic studies linking method parameters to formulation variables.
  • Support the dissolution method lifecycle including validation, method transfers, and troubleshooting.
  • Build and validate PBPK/PBBM models for oral absorption predictions.
  • Design biorelevant dissolution experiments to support mechanistic absorption modeling.
  • Collaborate with formulation scientists to guide formulation selection based on dissolution results.
  • Engage with the external scientific community through publications and conference presentations.

Benefits

  • 401(k) and pension participation
  • Medical, dental, and vision benefits
  • Flexible spending accounts for healthcare and dependent care
  • Life insurance and death benefits
  • Wellness benefits including an employee assistance program and fitness benefits.
Full Job Description
Organizational Details:

The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs advances small molecules, peptides, and oligonucleotides from early discovery through commercialization. Our scientists and engineers develop innovative technical solutions across a broad portfolio of projects, applying deep technical expertise to accelerate overall drug development and bring the next generation of life-changing medicines to patients.

We are looking for a scientist who can combine deep understanding of dissolution science with biopharmaceutics modeling capability to enable robust control strategies for new products. You'll develop dissolution methods that are suitable for worldwide regulatory submissions, robust enough to operate in a quality control environment, and relevant to clinical performance. You'll also design and conduct biorelevant dissolution experiments to generate the input data for biopharmaceutics risk assessments and physiologically based pharmacokinetic/biopharmaceutics (PBPK/PBBM) models, connecting in vitro performance and in vivo prediction.

Responsibilities:

Dissolution Method Development
  • Develop and optimize dissolution methods for oral solid dosage forms (immediate-release and modified-release) that detect meaningful changes in critical quality attributes while performing reliably across analysts, instruments, and sites.
  • Justify the discriminating nature of proposed methods through systematic studies linking method parameters to formulation and process variables, generating data packages that withstand regulatory scrutiny.
  • Support the dissolution method lifecycle, including validation, method transfers, and troubleshooting.
  • Develop and justify phase-appropriate dissolution specifications, including clinically relevant acceptance criteria.


Biopharmaceutics Modeling & In Vivo Prediction
  • Build, parameterize, and validate PBPK/PBBM models to predict oral absorption, assess formulation bridging risk, and establish the clinical relevance of dissolution methods and specifications.
  • Design and execute biorelevant dissolution and solubility experiments that generate input data for mechanistic absorption models.
  • Support biowaiver justifications, in vitro-in vivo correlation/relationship (IVIVC/IVIVR) dossiers, and bioequivalence safe space assessments using integrated in vitro and in silico data.


Drug-Product Performance & Regulatory Interface
  • Partner with formulation scientists to guide formulation selection and process decisions based on dissolution testing results and model predictions.
  • Author and defend dissolution and biopharmaceutics content in regulatory submissions and responses to health authority questions.
  • Collaborate with clinical pharmacology and regulatory colleagues to align dissolution and biopharmaceutics strategies with clinical development plans and post-approval lifecycle management.
  • Represent product performance on multidisciplinary project teams.


External Engagement & Growth
  • Engage the external scientific community through publications, conference presentations, and collaborations in dissolution science and biopharmaceutics.
  • Stay current with evolving regulatory expectations for dissolution methods, modeling approaches, and product performance control strategies.


Minimum Requirements:
  • Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, or Chemical Engineering with 0-5 years of directly relevant experience in dissolution method development and/or biopharmaceutics; or
  • M.S. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, or Chemical Engineering with 5+ years of directly relevant experience in dissolution method development and/or biopharmaceutics; or
  • B.S. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, or Chemical Engineering with 8+ years of directly relevant experience in dissolution method development and/or biopharmaceutics.
  • Working knowledge of physicochemical characterization techniques relevant to oral drug product performance (e.g., dissolution, solubility, permeability, particle size, solid-state characterization, HPLC, UV/Vis).


Additional Skills and Preferences:
  • Experience with PBPK/PBBM platforms (e.g., GastroPlus, Simcyp, DDDPlus, SIVA) and their application to clinically relevant dissolution method development, specification setting, or in vivo performance assessment.
  • Experience designing dissolution methods and planning for the full method lifecycle.
  • Knowledge of regulatory expectations for dissolution method development and justification, for worldwide marketing authorizations.
  • Proficiency with scripting languages (R, Python, or MATLAB) for data analysis, model parameterization, or automated reporting.
  • Strong scientific writing skills and external publication record.


Additional Information:
  • Ability to travel 0-10%
  • Location: LTC N, Indianapolis IN


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600

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

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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