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Scientist Analytical Biochemistry

Location: San Diego, CA, United States
Job # 10269988
Date Posted: 12-22-2017
Scientist Analytical Biochemistry
San Diego, CA 92121
6 Month Contract (Strong Potential to Convert or Extend)
Pay: $40-50/hour (Depends on Experience)
Start Date: ASAP
  
Client Overview
Our client is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. We have the highest-quality protein production and bioanalytic technology platform approach that allows us to create biosimilars in a highly efficient manner from concept to commercialization.

Job Description
We are looking for a Scientist to be a key member of the Analytical Biochemistry Group. This Scientist is responsible for executing analytical and biochemical characterization activities for biotherapeutic protein product development, including assay development, assay qualification, and product characterization. This position must effectively communicate timelines and issues to ensure successful manufacturing, product testing/release and data package for regulatory filings. Individual technical issue management and cross functional communication are key position attributes.

Responsibilities:
  • 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 company & CMO and/or our partner.
  • 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
Education/Experience:
  • BS, MS, or PHD in Physical, Chemical or Biological Sciences or Engineering or other applicable field
    • or 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 months years of relevant industry experience
  • 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
Supplemental Experience as a 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
Please submit your resume in PDF or Word format to be in consideration. #DI
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