Position Summary:
Lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. Lead dynamic cross-functional teams.
Responsibilities:
- Apply expertise in unit operation design, process modeling, equipment selection, and scale-up; challenge existing methods and use cutting-edge technology/time-constrained platforms.
- Use modern synthetic organic chemistry knowledge.
- Demonstrate high learning agility across disciplines; apply learnings to small molecule, oligonucleotide, and synthetic peptide modalities.
- Design/develop new synthetic routes for API manufacture using continuous processing, automated reaction screening, PAT, and modeling/simulation.
- Lead cross-disciplinary teams to evaluate/refine manufacturing routes, technologies, and practices.
- Translate scientific hypotheses into action under uncertainty.
- Provide technical guidance for scale-up/demonstration of chemical processes; participate in technology transfer to CRO/CMO and Lilly manufacturing.
- Design experiments for process design/definition/optimization and technology transfer; generate process/property design data; use PAT and modeling to direct protocols.
- Plan/manage short- and long-term development; set technical agendas/timelines; recommend resources; communicate progress and propose changes.
- Collaborate with internal/external manufacturing partners to enable robust, efficient drug substance manufacturing.
- Collaborate with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to deliver materials/information.
- Communicate effectively; supervise/mentor staff; encourage knowledge sharing.
- Monitor and apply external scientific innovation; understand global regulatory climate and address CMC regulatory questions.
Basic Qualifications:
- Ph.D. in chemical engineering (8+ years) or MS (15+ years).
- Experience developing chemical processes from proof of concept through commercialization.
- Required: technical transfer of processes into manufacturing operations.
- Pharmaceutical sector desired (other relevant sectors may qualify); API and associated formulated product experience acceptable.
Additional Skills/Preferences:
- Authoring regulatory submissions; responding to regulatory questions.
- Modeling/simulation, data analytics, predictive analytics.
- Online/offline analytical techniques and PAT.
- Technical leadership/project management; creativity; collaboration; change management; persuasion/influence/negotiation.
- Ability to prioritize multiple activities and manage ambiguity; initiative/risk-taking; strong communication; external publication record.
Additional Information:
- Travel: 0β10%.
- Position Local: Indianapolis, IN (Lilly Technology Center-North, LTC-N).