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Senior Scientist Downstream Processing / Formulation

Location: San Diego, CA, United States
Job # 10267801
Date Posted: 12-21-2017
Senior Scientist, Downstream Processing / Formulation
San Diego, CA 92121
6 Month Contract (Strong Potential to Convert or Extend)
Pay: $50-60/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 Senior Scientist to serve as a member of the process development/characterization team focused on late-stage characterization of downstream unit operations, prior to process validation. Proficiency in all aspects of chromatography development is required. Competency in clarification techniques, such as continuous centrifugation, depth/membrane filtration is preferred. Position scope extends from bench to pilot-scale activities, DOE execution, data summarization and report generation. Individual technical issue management and effective communication are key position attributes. The candidate will work in a team environment, collaborating with various colleagues in process and product development, and will report to the Director of Product/Process Development.

Responsibilities:
  • Characterization of drug product formulation process
  • Experience in affinity, ion-exchange, hydrophobic interaction and mixed-mode chromatography techniques
  • Statistical experimental design and analysis (JMP experience preferred)
  • Develops experimental protocols, executes laboratory experiments and authors reports in accordance with Good Documentation Practice and scientific principles
  • Scientifically characterizes drug substance and/or drug product manufacturing processes
  • Proactively troubleshoots and mitigates complex technical issues associated with primary recovery, chromatography processes and formulation
  • Authors technical detailed development reports and provides input/data for manufacturing documents and regulatory submissions
Education/Experience:
  • BS, MS, or PHD in Physical, Chemical or Biological Sciences or Engineering or other applicable field
    • or BS 8 years of relevant experience w/a minimum of 5 years of industry experience
    • or MS 5 years of relevant experience w/a minimum of 3 years of industry experience
    • or PhD 2 years of relevant industry experience
  • Demonstrated experience in drug product formulation development or characterization
  • Experience in design and analysis of stability of drug substance and drug product
  • Experience in product recovery/clarification, chromatography, filtration, PAT, and high throughput screening (HTS) technologies
  • Experience with AKTA chromatography systems and Unicorn software, as well as filtration methods including normal flow and TFF
  • Scientific understanding of current purification technologies, as well as the ability to explore and develop novel approaches to further advance innovative purification technologies
  • Exceptional organizational skills
  • Proven working knowledge of GDP, GLP & cGMP compliance and ISO9000
  • Fluent in practical application of PC's, Microsoft Project, Word, Excel, PowerPoint as well as statistical experimental design and analysis software (e.g., JMP)
  • Proven ability to work in a lean organization and creatively tackle problems.
  • Work independently in a matrix environment and manage multiple tasks simultaneously.
  • Experience in process characterization within a biosimilar process development organization
  • 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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