Project Lead, Process Chemistry
Project Lead (Process Chemistry)
- Ability to lead 1-2 process development projects with minimal to no supervision.
- Good knowledge of process development of small molecule drug candidates.
- Able to tackle both chemistry and process related challenges by coming up with practical ideas and arriving at optimal solutions quickly to minimize impact on project timelines.
- Oversee and guide a team of chemists to complete the development and execution of multistep campaigns.
- Actively work in the lab to develop and execute portions of the processes they are guiding.
- Guides the collection of safety data related to the process to ensure safe scale up.
- Provide chemists with guidance and training as necessary to ensure successful development of their process chemistry knowledge.
- Provide chemists with guidance related to GMP processing and how to ensure the correct controls are developed in the process to allow for GMP manufacturing.
- Ensure process chemists are generating high quality processes by providing guidance on evaluation of operating ranges, stability and hold points, data driven decision points, safety considerations, and cost effectiveness.
- Oversee their team’s generation of processing directions (for GMP and non-GMP execution), and project reports.
- Support their team’s scale up of processes in the kilo labs, highly potent compound suite, and pilot plant in both GMP and non-GMP environments.
- Ensure appropriate acquisition of chemical starting materials through the local Manager of Chemical Development or through procurement groups in Italy and China.
- Collaborate with analytical chemists, operations staff, and QA to ensure successful completion of campaigns and release of raw materials, intermediates, and final products.
- Act as the primary contact for customers to provide technical updates on the project progress.
- Typically, MS(Chemistry) w/ 15+ years relevant experience, or PhD (Organic Chemistry). w/ 8+ years relevant experience.
- Working knowledge of analytical equipment/instruments such as HPLC, GC, DSC, TGA, KF, NMR, LCMS, and GCMS is required.
- Familiarity with GMP regulations required.
- Excellent organizational and communication skills required.