Principal Scientist - Bioassay Development

94538, Fremont
Nov 03, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

Job Description

  • Responsible for leading method development, optimization, and phase-appropriate qualification of custom bioassays for clients per ICH guidelines, meeting defined project timelines and producing high quality data and reports
  • Participates in intake phone calls with new clients to establish project requirements and deliverables, and teleconferences with clients to communicate progress of on-going projects
  • Oversees development, troubleshooting, and qualification of new bioassays in product portfolio intended for potency / lot release or neutralizing antibody (NAb) applications.
  • Implements design of experiment (DoE) approaches in bioassay development and qualification process to understand performance characteristics and improve robustness of DiscoverX bioassays
  • Writes detailed methods to facilitate assay transfer and documents critical manufacturing information in the development of ready-to-use cell banks and transfers to Cell Manufacturing team
  • Serve as liaison between the Bioassay, Cell Manufacturing, Customer support and Marketing teams to ensure successful implementation of DiscoverX bioassays at customer sites
  • Prepares and collaborates with QA and Marketing in finalizing all appropriate documentation (SOPs, user manuals, qualification reports, etc.) to support product launch or transfer of assays / methods to client sites
  • Participates in method transfer phone calls with clients, and training of DiscoverX technical support staff who will be responsible for training employees at client sites to transfer methods
  • Prepares data and scientific content for presentations, posters, webinars, manuscripts, white papers, or other relevant company materials
  • Demonstrates and promotes the company vision
  • Conducts all activities in a safe and efficient manner
  • Performs other duties as assigned
  • Owns the accountability and responsibility of delivering to client needs and timelines
  • Provides cross-functional support to other departments as required
  • Adjusts work hours as needed to meet client deadlines
  • Adheres to site employee health and safety (EHS) requirements