Principle Scientist, CMC (1316)

By Posted in - on April 11th, 2017 0 Comments
Adante Staffing Inc. Published: June 23, 2017
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Job Type

Description

Responsibilities include:

  • developing drug substance programs from preclinicial through validation
  • manage transfer of development candidates from Discovery to Development (internal) and technology transfer/selection to CMO’s (external)
  • contribute to CMC regulatory documents

Requirements:

  • PhD in engineering or chemistry w/5+ yrs. exp. in process development specifically developing drug substance, ADC a plus
  • Design of Experiment to advance process development
  • Experience using and interpreting various analytical characterization techniques (SEC, HIC, SDS-PAGE, etc) and chromatography purification techniques (IEX, SEC, etc).
  • Experience working with CMO’s and building strong, collaborative relationships.
  • Strong understanding of cGMP, ICH and regulatory guidelines as they relate to risk management for clinical and commercial manufacturing.
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