Process Scientist III
Date Posted
1/5/23
Location
Malvern, PA
Position Id
1890
Degree Required
Job Type
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.