Drug Product Design & Development Lead

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Job summary

Lilly, headquartered in Indianapolis, IN, is advancing life-changing medicines through integrated drug product design and development. This role focuses on combining early discovery with preclinical and clinical activities to accelerate formulation and manufacturing solutions for synthetic molecules.

The successful candidate will work within the SMDD team to advance phase-appropriate drug products, collaborating with cross-functional partners to mitigate risks and support regulatory submissions.

Qualifications

• PhD in Pharmaceutical Sciences or related field with 0–5 years of pharmaceutical product development experience.
• Experience in drug product design and development.
• Knowledge of solid-state properties and quality attributes.
• Understanding of regulatory/GMP aspects.

Responsibilities

• Design and optimize phase-appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
• Predict in vivo performance of drug molecules and formulations using molecular properties and preclinical data.
• Refine clinical drug product prototypes and mitigate technical risks to enable commercial products.
• Collaborate with partners to plan and manage short/long term development activities aligned with global CMC strategy.
• Author and review high quality technical reports and regulatory documentation to support new technologies and regulatory submissions.
• Engage with internal and external scientific communities to solve technical challenges.

Skills

Formulation science

Biopharmaceutics

Solid-state chemistry

Drug product development

Team leadership

Education

PhD in Pharmaceutical Sciences

Job description

Lilly, headquartered in Indianapolis, IN, is advancing life-changing medicines through integrated drug product design and development. This role focuses on combining early discovery with preclinical and clinical activities to accelerate formulation and manufacturing solutions for synthetic molecules.

The successful candidate will work within the SMDD team to advance phase-appropriate drug products, collaborating with cross-functional partners to mitigate risks and support regulatory submissions.