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, integrating pharmaceutical sciences with disease state and patient preferences. Responsibilities include applying drug delivery fundamentals, predicting in vivo performance using molecular properties and preclinical data, leveraging modeling for formulation development, refining clinical drug product prototypes, and collaborating with partners on CMC strategy. The role also involves authoring technical reports and regulatory documentation.

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. Leverage modeling to guide the development of preclinical and clinical formulations to enable the delivery of a broad range of synthetic molecules.
  3. Refine clinical drug product prototypes, identify and mitigate technical risks to enable commercial products.
  4. 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.
  5. Engage and influence internal and external scientific communities. Develop collaborations to solve technical challenges, identify and implement novel drug delivery and manufacturing technologies, influence clinical study design to benefit our patients.

Skills

Required

  • formulation development
  • biopharmaceutics
  • solid state
  • drug delivery fundamentals
  • preclinical and clinical formulations
  • molecular properties
  • preclinical data
  • CMC strategy

Nice to have

  • solid-state forms
  • physical properties of pharmaceutical solids
  • product quality
  • performance attributes
  • process development
  • technical considerations for equipment design and integration
  • process monitoring
  • process analytical technology (PAT) systems
  • control strategies
  • modeling and simulation tools
  • data analytics
  • predictive analytics
  • drug product manufacturing unit operations
  • continuous manufacturing
  • regulatory/GMP aspects

What the JD emphasized

  • Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or other related fields with 0-5 years of demonstrated experience in pharamaceutical product development.