Principle Scientist, CMC (1316)
Adante Staffing Inc. Published: June 23, 2017
- 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
- 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.