Seeking experienced and creative individuals to lead late-phase synthetic molecule process development, including finalizing commercial route and process, characterizing the process, and defining the control strategy to support Phase 3 clinical supply, registration stability, regulatory submissions, process validation, and commercial hand-off.
The anticipated wage for this position is $153,000 - $264,000
- Demonstrate a deep expertise and demonstrated capability in the utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges
- Lead and/or supervise the finalization of commercial synthetic routes and the development of robust, scalable, and well-characterized API manufacturing processes, including starting materials selection and justification of the commercial route
- Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives
- Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple fields; be able to apply these takeaways to a dynamic portfolio of small molecule programs
- Possess solid understanding in unit operation design and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment
- Ph.D. in organic chemistry
- MS in Organic Chemistry
- Nice to have: pharmaceutical sector experience
- Nice to have: active ingredient development
- Nice to have: formulated product experience
- company bonus
- 401(k)
- pension
- vacation benefits
- medical
Director Early Phase Process Development SMDDLilly · Indianapolis, US