Tanabe Research Laboratories USA (www.trlusa.com) located in San Diego, California is a cutting-edge biotechnology company dedicated to the discovery and advancement of innovative therapies to treat cancer and other serious diseases. This position is located onsite at our San Diego facility.

JOB SUMMARY

Under guidance, designs, implements and analyzes scientific studies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Proposes, initiates, directs, and executes biologic pre-clinical drug development projects working with antibodies or other biologics targeting oncological diseases.
  • Leads TRL’s bioanalytical science to support non-clinical and clinical projects, including PK, ADA and biomarker assay development, validation and sample testing for antibody-based therapeutics that include antibody drug conjugates (ADCs) and other modified antibody therapeutics
  • Establish bioanalytical capabilities for assessment of drug pharmacokinetic (PK) pharmacodynamic (PD), immunogenicity, biomarkers in house or through CROs.
  • Manage and oversee CRO outsourcing studies in various animal species. This would involve designing studies and analyses of the data generated in consultation with available consultant experts.  This could also involve toxicokinetic (TK) evaluations.
  • Uses bioinformatics software for the analysis of various properties of proteins.
  • Oversee bioanalytical functions, including reagent screening and development of immunoassays for GLP and non-GLP PK and ADA studies.
  • May discover innovative technologies to improve the efficiency of laboratory operations.
  • Interacts with and provides scientific critique of analytical and bioanalytical CRO efforts to develop assays adequate for full characterization of molecules in the development phase
  • Analyzes and presents data to scientific team for in-depth discussions.
  • Independently and effectively troubleshoots complex issues.
  • Lead projects and interacts with project leaders and members of project teams to coordinate the efforts for assigned projects.
  • Analyzes data and interprets results in clear format for presentation during project team meetings and project reviews.
  • Integrates results into larger project goals and deliverables.
  • Prepares reports and manuscripts of completed projects for publication in technical journals, presentation to: regulatory agencies; partners/collaborators; and at conferences or use in further research and development activities.
  • Participate in and support Company’s regulatory submission efforts and prepare technical reports in support of planned regulatory submissions.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

  • A PhD or equivalent in the biological sciences.
  • 5-10 years related industry experience in biologics bioanalytical field with expertise in assay development and validation.
  • Extensive experience in antibody PK studies and related analyses in various species
  • Experience with ADCs and other antibody-based therapeutics would be preferred
  • Experience working under a GLP regulatory environment and preparing corresponding sections for IND/BLA submission
  • Strong communication and leadership skills, cross-functional team leadership abilities are required
  • 5 years’ experience managing other research staff
  • Extensive knowledge of scientific principles and concepts.
  • Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
  • Excellent record keeping, attention to detail and communication skills.
  • Strong written, verbal, organizational and interpersonal skills.
  • Ability to change tasks quickly and still maintain attention.
  • Ability to regularly lift, push, or pull up to 25 pounds.