Process Scientist III

Job Description

Process Scientist III

A growing CDMO that has a site dedicated to the development and production of APIs ranging from pre-clinical / clinical to small scale commercial phase manufacturing, is looking for a Process Scientist to join their team. The responsibilities of this role will include:

• Design experiments to evaluate and develop synthetic routes to small molecule targets.
• Perform process characterization in terms of impurities synthesis and identification, fate and purge studies, definition of critical process parameters to ensure efficient and successful scale up.
• Evaluate safety of processes utilizing calorimetry data and stability data to fully understand the hazards and the trigger points of these hazards.
• Perform safety assessments of raw materials.
• Ability to solve complex synthetic problems during development or troubleshoot issues that occur during production.
• Execute scale up of processes in the kilo labs in a GMP environment.
• Support scale up of processes in the pilot plant in a GMP environment.
• Collaborate with analytical chemists, operations staff, and QA to ensure successful completion of campaigns and release of raw materials, intermediates, and final products.
• Accurately collect reliable data in the form of lab procedure or reports to be used for updates to customers or during drafting of production’s MBR.
• Supervise work performed by Process Scientists I/II.
• Contribute to SOPs writing for process related procedures.

Qualifications:

• MS, or PhD (Organic Chemistry).
• 3+ years of relevant experience in API manufacturing companies required and experience in kilo-scale productions (non-GMP or GMP) required.
• Knowledge of analytical equipment/instruments such as HPLC, GC, DSC, TGA, KF, NMR, LCMS, and GCMS required.
• Familiarization and/or experience in QBD and DOE studies preferred.
• Experience in managing projects autonomously preferred.
• Familiarity with GMP regulations required.
• Excellent organizational and communication skills required.
• Strong problem-solving skills.