Research Advisor, Drug Product - Smdd

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

This role focuses on the design and development of drug products for synthetic molecules within the pharmaceutical industry. It involves applying fundamental pharmaceutical sciences, predicting in vivo performance using molecular properties and preclinical data, and leveraging modeling to guide formulation development. The position also requires collaboration with partners, influencing scientific communities, and authoring technical reports and regulatory documentation. While it involves modeling and data analytics, the core function is not AI/ML model development but rather drug product research and development in a healthcare context.

What you'd actually do

  1. Apply drug delivery fundamentals towards designing and optimizing phase appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
  2. Predict and assess the in vivo performance of drug molecules and formulations in preclinical species and humans using molecular properties and preclinical data.
  3. Leverage modeling to guide the development of preclinical and clinical formulations to enable the delivery of a broad range of synthetic molecules.
  4. Refine clinical drug product prototypes, identify and mitigate technical risks to enable commercial products.
  5. Collaborate and communicate project specific challenges and opportunities with key partners to plan and manage short/long term development activities aligned with the global CMC strategy.

Skills

Required

  • Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or other related fields.
  • M.S. with 6+ years of demonstrated equivalent experience in a related field of expertise.
  • B.S. with 10+ years of demonstrated equivalent experience in a related field of expertise.
  • General understanding of solid-state forms, screening, and instrumentation used in characterizing physical properties of pharmaceutical solids.
  • Experience in developing the relationship of these properties to product quality, performance attributes, and process development.
  • Experience in technical considerations for equipment design and integration, process monitoring, integration of process analytical technology (PAT) systems, and scientific approaches on control strategies.
  • Involvement with modeling and simulation tools, data analytics and predictive analytics.
  • Experience in design, development, control, and optimization of drug product manufacturing unit operations, especially knowledge in continuous manufacturing within the pharmaceutical industry.
  • Experience supervising or guiding the work of other scientists.
  • Basic understanding of regulatory/GMP aspects pertaining to development and clinical testing of drug products.