Director - Process Chemistry

6w1 month ago

Eli Lilly and Company

Indianapolis, US · Full-time · $148,500 – $257,400

About this role

The Synthetic Molecule Design and Development team develops synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Chemists, engineers, and scientists accelerate testing of the clinical hypothesis using deep technical expertise across the portfolio.

Directors lead synthetic molecule route commercialization along with process optimization and unit operation definition to support clinical trials, product commercialization, and regulatory submissions. The role includes oversight of external R&D, tech transfer, and campaign execution at CRO and CMO organizations.

Cross-disciplinary teams of process chemists, analytical chemists, formulation scientists, and engineers evaluate new manufacturing routes and technologies. Technical leadership is provided during scale-up in development and commercial equipment while ensuring processes are robust and safe.

Advancements in PAT, modeling platforms, and high-throughput experimentation accelerate reaction discovery and process understanding. Short-term and long-term development activities are planned with technical agendas and resource allocation aligned to project timelines.

Requirements

Demonstrated expertise with modern synthetic organic and process chemistry techniques to address CMC challenges
High learning agility to understand and exploit new scientific concepts across small molecule, oligonucleotide, and synthetic peptide modalities
Solid understanding of unit operation design, process modeling, equipment selection, and scale-up methodologies
Ability to integrate process data based on fundamental understanding of underlying physical processes

Responsibilities

Lead the design and development of new synthetic routes for API manufacture using modern technologies
Provide technical leadership in scale-up and demonstration of new chemical processes in development and commercial equipment
Collaborate on technology transfer to CRO/CMO organizations and internal manufacturing nodes
Design experimental laboratory plans supporting route and process definition, optimization, and technology transfer
Lead cross-disciplinary teams to evaluate and refine manufacturing routes, technologies, and practices
Apply PAT and modeling platforms to guide experimental protocols and leverage high-throughput platforms for reaction discovery