Protein Characterization Scientist

92121, San Diego
Apr 11, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Our client, a leading developer of protein purification systems and products, is seeking an Analytical Biochemist to join their expanding team. 


Technical Scope

  • Serve as Analytical Biochemistry (AB) subject matter expert in the development/ commercialization of recombinant proteins that requires knowledge and application of analytical technologies involving primarily HPLC separations, SDS-PAGE, Western blots, UV-Vis spectrophotometry, and other analytical protein characterization methods
  • Responsible for developing method robustness and other analytical parameters prior to analytical method Tech Transfer to QC CMO for validation
  • Facilitate and lead method transfers between our CMO and/or partners
  • Partner with a diverse team of Process Development/ Characterization Scientists in USP, DSP and Analytical Biochemistry that support the advancement of a broad portfolio of products
  • Provides expertise, guidance, and feedback on protein analytical results so as to direct effective purification development and product/process control strategies
  • Keeps current in analytical method development including literature and technology development and regulatory driven activities
  • Author/Review detailed analytical reports and provides direct input/data/statistical analysis to support data package for regulatory submission(s)
  • Interface with contract manufacturing or research organizations (CMOs/CROs) in the execution of analytical method transfer, testing, and release and stability studies
  • Assembles and delivers CMC supporting regulatory documentation required to rationalize process analytical, characterization, and release specifications
  • With minimal supervision, generates and delivers concise/clear technical presentations to senior management
  • Other duties as assigned or required


  • A minimum of a Bachelor's degree in Analytical Chemistry/Biochemistry/Biochemical Engineering/Biology or related field with biosimilar and/or biologics experience required
    • BS 5 years of relevant experience w/a minimum of 5 years of industry experience
    • or MS 3 years of relevant experience w/a minimum of 3 years of industry experience
    • or PhD 6 to 12 months of relevant industry experience
  • Ability to travel up to 10% (US and Internationally)
  • Fluent in practical application of PC’s, Microsoft project, Word, Excel, Power point and experience to include data analyses, statistical analysis (JMP), method transfers and comparability studies
  • Experience in developing and qualifying analytical methods, primarily HPLC separations
  • Scientific understanding of current analytical technologies, as well as the ability to explore and develop novel approaches to further advance innovative analytical methodologies
  • Proven working knowledge and understanding of GxP (GLP, cGMP, GCP and ISO9000) environments and regulations required
  • Ability to work flexible work schedules
  • Analyzes reports, metrics and results as required; provides SME and strategic guidance based on findings
  • Excellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic
  • Possesses and demonstrates exceptional research and resource utilization skills as well as practical problem solving capabilities
  • Proven ability to work in a lean organization and creatively tackle problems using colleague networks and publicly available solutions; work independently and successfully in a matrix environment; and prioritize and manage multiple tasks simultaneously
  • Other duties as assigned or required

Supplemental Experience (Strong Plus)

  • Experience working in a biosimilars drug-development organization highly preferred
  • Experience with the full product lifecycle of a biopharmaceutical product (i.e. Phases 1 – 4) highly preferred
  • Working knowledge of U.S. Government-funded programs is preferred