Project Lead (Process Chemistry) - Flamma spa

Responsibilities:

·         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.

Qualifications: 

·         Typically, BS w/ 10+ years relevant experience, MS(Chemistry) w/ 8+ years relevant experience, or PhD (Organic Chemistry). w/ 5+ 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.