Process Scientist III

1/5/23

Malvern, PA

1890

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.
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