Process Chemist II/III

Malvern, PA

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Type: Direct-Hire

Experience: 0

Category: Scientific & Clinical

Brand: Joule

Job ID: 292759

Date Posted: 01/17/2023


Title: Process Chemist II/III
Location: Malvern, Pa
Schedule: M-F 8-5pm
Type: Permanent/Direct
Start date: Immediate

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.


  • 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.
  • Ability to lead multiple process development projects with minimal supervision.
  • 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.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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