Sr. Scientist, Drug Substance & Manufacturing

BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Scientist to work for a leading San Diego biotechnology company.


Sr. Scientist, Drug Substance & Manufacturing


Summary:
The Technical Operations group is responsible for all drug substance and drug product manufacture and testing, including sourcing and testing of raw materials, starting materials and excipients. This hands-on role will report directly to the Head of Drug Substance & Manufacturing.  
 
The Drug Substance and Manufacturing Scientist affords considerable opportunity to drive chemical process development and scale-up projects, interface extensively with external contract service providers and participate in multidisciplinary project teams.  Working on projects spanning the entire pharmaceutical development spectrum from discovery through commercial product supply, this role will be key in a corporate environment that is committed to developing and delivering novel, high quality pharmaceutical products to patients in need of safe and effective treatment options in a wide range of clinical indications
 
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
  • Location: San Diego
  • Type: Permanent
  • Job ID: SH6442141012