Previous Job
Ref No.: 18-20701
Location: Irvine, California
Location: Irvine, CA, 92612
Duration: 7 Months
Main Areas of Responsibilities
  • Executes the development and qualification of analytical methods for the biologics drug product development with an emphasis on SMCxPRO (Singulex Erenna) immunoassay.
  • Creates written procedures and protocols.
  • Responsible for creating detailed project plans including scientific strategy. Actively involved in the planning, execution and management of experimental studies.
  • Organizes, schedules and participates in project team meetings to define and schedule project activities and review completed tasks.
  • Communicates project status to supervisor, and/or project team leader,
  • Writes, reviews and issues technical reports, technical memoranda and other documents for internal and external distribution.
  • Experience in a developing immunoassay with a proven record of success in conducting R&D projects.
  • Must have a thorough working knowledge of a wide range of analytical methods (i.e Singulex Erenna, SMCxPRO, Luminex, ELISA, MSD).
  • Ability to independently develop new and innovative analytical methods, improving existing ones, and troubleshoot product quality problems.
  • Previous experience with biologics and/ or hydrogels is a plus.
  • Strong ability to evaluate and interpret analytical results and lead investigations to resolve analytical issues is required.
  • Proficient in writing technical reports, protocols, and procedures.
  • Strong verbal and written communication skills, strong scientific leadership skills, ability to work effectively in independent and team settings, and acute attention to detail are essential skills for this position.
Preferred Skills/Qualification
  • Working knowledge in analytical development
  • Must be knowledgeable using statistical programs for analytical data evaluation.
  • Ability to critically review and evaluate analytical data and make conclusions/recommendations based on data.
  • Must possess good interpersonal skills, the ability to work in a dynamic team environment and must multi-task to meet project timelines.
  • Ph.D. and 2+ years of industry experience or Master's degree and 4+ years of industry experience. Degree in a related scientific or engineering discipline (cell biology, molecular biology, immunology or similar).