Research Advisor, Drug Product - SMDD
Eli Lilly and Company
18 days ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Apply drug delivery fundamentals to design and optimize phase-appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
- Predict and assess in vivo performance of drug molecules and formulations in preclinical species and humans using molecular properties and preclinical data; use modeling to guide formulation development for delivery of a broad range of synthetic molecules.
- Refine clinical drug product prototypes; identify and mitigate technical risks to enable commercial products.
- Collaborate and communicate project challenges/opportunities to plan and manage short/long-term development aligned with global CMC strategy.
- Engage and influence internal/external scientific communities; develop collaborations to solve technical challenges and implement novel drug delivery/manufacturing technologies; influence clinical study design.
- Author/review technical reports, peer-reviewed publications, and regulatory documentation to support new technologies and/or regulatory submissions.
Basic Requirements:
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or related field; 0–5 years of demonstrated experience in pharmaceutical product development.
Additional Skills/Preferences:
- Solid-state forms/screening/instrumentation knowledge; link solid properties to product quality/performance and process development.
- Equipment design/integration, process monitoring, PAT integration, control strategies; modeling/simulation, data & predictive analytics.
- Drug product manufacturing unit operations experience, including continuous manufacturing.
- Experience supervising/guiding other scientists.
- Basic knowledge of regulatory/GMP aspects for development and clinical testing of drug products.
Additional Information:
- Possible exposure to chemicals, allergens, and loud noises.
- Travel: 0–10%.
- Onsite: Monday–Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N).
- Apply drug delivery fundamentals to design and optimize phase-appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
- Predict and assess in vivo performance of drug molecules and formulations in preclinical species and humans using molecular properties and preclinical data; use modeling to guide formulation development for delivery of a broad range of synthetic molecules.
- Refine clinical drug product prototypes; identify and mitigate technical risks to enable commercial products.
- Collaborate and communicate project challenges/opportunities to plan and manage short/long-term development aligned with global CMC strategy.
- Engage and influence internal/external scientific communities; develop collaborations to solve technical challenges and implement novel drug delivery/manufacturing technologies; influence clinical study design.
- Author/review technical reports, peer-reviewed publications, and regulatory documentation to support new technologies and/or regulatory submissions.
Basic Requirements:
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or related field; 0–5 years of demonstrated experience in pharmaceutical product development.
Additional Skills/Preferences:
- Solid-state forms/screening/instrumentation knowledge; link solid properties to product quality/performance and process development.
- Equipment design/integration, process monitoring, PAT integration, control strategies; modeling/simulation, data & predictive analytics.
- Drug product manufacturing unit operations experience, including continuous manufacturing.
- Experience supervising/guiding other scientists.
- Basic knowledge of regulatory/GMP aspects for development and clinical testing of drug products.
Additional Information:
- Possible exposure to chemicals, allergens, and loud noises.
- Travel: 0–10%.
- Onsite: Monday–Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N).