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Associate Director / Director, Process Development – San F

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San Francisco Bay Area, CA
$1 - $1
Job Type
Direct Hire
Mar 22, 2017
Job ID
   Associate Director / Director, Process Development – San Francisco Bay Area
  • Process Development of small molecule oncology drug candidates from research to validation
  • Subject Matter Expert for process chemistry.  Attend CMC meetings, provide status assessments and technical expertise
  • Experienced organic chemistry skills and leadership abilities to oversee outsourced projects at CRO/CMO
  • Create technology transfer, scale up and late stage supply chain strategy.  Evaluate process impurities and resolution for elimination and control
  • Create control strategy, process acceptance ranges, and prepare documents for validation campaign
  • Lead process improvement and clinical batch manufacturing CMO
  • Collaboratively work with multiple groups to support the development of the API supply chain in preparation for the NDA and commercial launch
  • Assist Regulatory Affairs with writing and reviewing submission sections
  • Maintain relevant data
  • Select CMOs
  • Travel up to 30%
  • MS or PhD, Organic Chemistry or Chemical Engineering (preferred)
  • Experience in a leadership role in drug substance process development and manufacturing, small molecule oncology preferred
  • Solid knowledge of process chemistry and scale-up
  • Proven track record in developing and implementing effective drug substance manufacturing processes
  • Technology transfer experience including troubleshooting of manufacturing processes
  • Extensive experience collaborating with and overseeing CMO’s
  • Exceptional communication,  and problem-solving abilities, must be a calm leader in a fast paced environment