Project Lead, Process Chemistry

11/23/22

Malvern, PA

1864

Project Lead (Process Chemistry)

Job Description:

  • Ability to lead 1-2 process development projects with minimal to no supervision.
  • Good knowledge of process development of small molecule drug candidates.
  • Able to tackle both chemistry and process related challenges by coming up with practical ideas and arriving at optimal solutions quickly to minimize impact on project timelines.
  • Oversee and guide a team of chemists to complete the development and execution of multistep campaigns.
  • Actively work in the lab to develop and execute portions of the processes they are guiding.
  • Guides the collection of safety data related to the process to ensure safe scale up.
  • Provide chemists with guidance and training as necessary to ensure successful development of their process chemistry knowledge.
  • Provide chemists with guidance related to GMP processing and how to ensure the correct controls are developed in the process to allow for GMP manufacturing.
  • Ensure process chemists are generating high quality processes by providing guidance on evaluation of operating ranges, stability and hold points, data driven decision points, safety considerations, and cost effectiveness.
  • Oversee their team’s generation of processing directions (for GMP and non-GMP execution), and project reports.
  • Support their team’s scale up of processes in the kilo labs, highly potent compound suite, and pilot plant in both GMP and non-GMP environments.
  • Ensure appropriate acquisition of chemical starting materials through the local Manager of Chemical Development or through procurement groups in Italy and China.
  • Collaborate with analytical chemists, operations staff, and QA to ensure successful completion of campaigns and release of raw materials, intermediates, and final products.
  • Act as the primary contact for customers to provide technical updates on the project progress.

Qualifications:

  • Typically, MS(Chemistry) w/ 15+ years relevant experience, or PhD (Organic Chemistry). w/ 8+ years relevant experience.
  • Working knowledge of analytical equipment/instruments such as HPLC, GC, DSC, TGA, KF, NMR, LCMS, and GCMS is required.
  • Familiarity with GMP regulations required.
  • Excellent organizational and communication skills required.
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