Role Overview
The Manufacturing Process Development Specialist is a critical team member responsible for delivering exceptional results in production schedules across key performance indicators including safety, quality, supply, and cost.
They will own the end-to-end process of clinical API manufacturing programs, collaborating with R&D project teams and overseeing technical transfer from early engagement to delivery.
1. Transfer of processes from R&D laboratories into the manufacturing facility.
2. Generation of optimal process configurations to meet requirements.
3. Troubleshooting plant batch and continuous manufacturing operations.
This role requires a B.Sc. in chemistry or engineering with 3-5 years' experience in commercial or clinical API small molecule manufacturing, new product start-up/tech transfer, and continuous manufacturing experience preferred.
Key Responsibilities:
* Clinical process development and implementation.
* Participation in co-development, launch, and tech transfer of processes between teams.
* Execution of flawless manufacturing against safety, quality, and customer service metrics.