Associate Process Scientist

Associate Process Scientist – Malvern, PA

Position Summary:

The Associate Process Scientist will play an essential role in executing laboratory experiments, supporting scale-up activities, and contributing to the safe and efficient development of processes within an API Contract Manufacturing and Development Organization (CMDO). This individual will assist senior scientists and project leaders with process development, safety evaluations, and scale-up efforts while familiarizing with GMP standards. The Associate Process Scientist will also collaborate closely with analytical chemists and contribute to the organization and maintenance of laboratory activities.

Responsibilities:

• Execute laboratory experiments.
• Assist in determining operational space for various process parameters to ensure efficient and successful scale up.
• Help evaluate safety of processes utilizing calorimetry data and stability data to fully understand the hazards and the trigger points of these hazards.
• Follow guidance from senior scientists or project leader to problem solve complex synthetic problems during development.
• Assist in scale up of processes in the kilo labs.
• Support scale up of processes in the pilot plant in a GMP environment.
• Collaborate with analytical chemists to complete work assignments.
• Contribute to laboratory organization (daily weigh checks, update of lab supplies inventory, lab supply purchase, lab cleaning, equipment calibration).
• 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.

Qualifications:

• BS or MS in Organic Chemistry
• 0-1 years of experience in API manufacturing companies preferred, but not mandatory
• Knowledge of analytical equipment/instruments such as HPLC, GC, DSC, TGA, KF, NMR, LCMS, and GCMS is preferred.
• Familiarity with GMP regulations preferred.
• Good organizational and communication skills required.