Ref No.: 18-12882
Location: Thousand Oaks, California
Position Type:Engg (T)
Start Date / End Date: 09/10/2018 to 12/31/2018
Our client, a leading biopharmaceutical company is looking for an Engineer. This is for an initial duration of 3 months and is located in Thousand Oaks, CA
 
Top Skill Sets:
  • Biologic Process support/monitoring, Cell Culture (e.g. bioreactor operation/harvest), biologic Purification (e.g. Purification/filtration)
  • MS in Chemical/Biochemical Engineer or other biological engineering discipline and 8 years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
  • Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance.
  • In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
AND/OR
  • In-depth understanding of cell culture process scale up, mass oxygen transfer, metabolism profiling, process deviation impact to growth and quality attributes, harvest/clarification processes, raw material including media component impact to cell culture. Good knowledge of aseptic processing/techniques.
  • Process validation, process characterization and process monitoring experience
  • Experience in supporting regulatory inspections
  • Process development experience in supporting cGMP manufacturing at large scale
  • Good written and verbal communication skills
  • Experience in preparing regulatory filings and participation in regulatory inspections
  • Process development and optimization experience with late stage or commercial products
  • Process equipment design and evaluation expertise
  • Experience with risk analysis methodologies
  • Independently motivated with ability to multi-task and work in teams
 
Description:
  • This individual will provide dedicated process engineering support for human therapeutic products (biological drug substance) in clinical development through commercial production.
 
Basic Qualification Requirements (Sr. Engineer)
  • Doctorate degree and 0-2 year of directly related experience OR
  • Master’s degree 6+ years of directly related experience OR
  • Bachelor’s degree and 8+ years of directly related experience
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.