Transfer Scientist

Possess cross-disciplinary knowledge and scientific leadership skills, to function in a multi-faceted capacity as, (1) an insightful, collaborative and decisive team member, (2) contribute to new technology/assay ideas. Expected to be an integral part of the stages of a project’s course from early project validation through transfer, and downstream support in the field, as needed. Critical in the identification of key assay development issues, proposing and implementing creative solutions to help team accomplishments. Must be scientifically curious and constantly looking to improve processes. Naturally effective in initiating and building collaborations cross functionally, both inside and outside the organization. Share and solicit best practice, both within and outside project team. The individual is expected to act as a source of expertise in assay transfer and to broadly impact both the R&D and Operations teams.

Responsibilities

  • Build strong relationships with cross-functional partners
  • Routinely work with other Scientists to transfer products from R&D to Operations
  • Responsible for oversight of formulation and testing of contract manufactured reagents applied in custom derived LDTs (Laboratory Developed Test) including both single- and multi-plex assays
  • Continuously looking for improvements in processes and methodologies, including document revisions
  • Solid understanding of CLSI performance guidelines
  • Customer support in evaluating or troubleshooting assays
  • Successfully plan and assist in executing various projects in support of product line/sales/marketing and company objectives and plans
  • Training of personnel (both internal and external) on the best practices of ELISA testing

Skills & Qualifications

  • Requires a BS/MS or its equivalent and 10-15 years of related experience or a PhD with 5-10 years of related experience
  • Extensive experience/knowledge of immunoassay development process (e.g. assay feasibility/performance data analysis, beads/plates coating chemistry, blood & tissue sample handling, protein chemistry)
  • Excellent project management and communication skills
  • Experience with standard concepts, practices, and procedures within the medical device industry including GMP and ISO standards
  • Good organizational, attentional to detail and follow-through skills
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