Sr. Scientist

Location
San Diego, CA
Posted
Oct 17, 2017
Discipline
Science/R&D
Required Education
Masters Degree/MBA
Position Type
Full time

Summary:

This position will be involved with chemical process development and scale-up projects, work with external contract service providers and participate in multidisciplinary project teams. Working on projects from discovery through commercial product supply.

 

Responsibilities:

  • Key member of the CMC project team to ensure supplies to support research, non-clinical, and clinical studies
  • Technical support to manage API process development and manufacturing activities 
  • Authoring detailed technical and manufacturing reports to document the process development
  • Technology transfers between manufacturing sites
  • Manage process characterization studies and critical parameter selection for late stage programs
  • Ensure GMP manufacturing performed at CROs and CMOs is in compliance
  • Authoring and reviewing documents related to GMP operations and Regulatory submissions

 

Requirements:

  • MS degree or Ph.D. in chemistry, chemical engineering or related field
  • 10+ years of proven experience in pharmaceutical small molecule synthesis, process development, scale-up and commercial scale manufacturing.
  • Experience working in a virtual pharmaceutical development environment managing CMO activities
  • Hands-on, collaborative and cross-functional leader
  • Exceptional personal management and organization skills 
  • Working knowledge of CFR/ICH/GMP etc.
  • Ability for occasional to travel to CMO sites

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