Advisor Dissolution Science & Biopharmaceutics - Smdd

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.

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

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

$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.

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