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Antibodies/ADC DMPK/T Lead (Senior Scientist/Principal Scientist)

Company: Tanabe Research Laboratories U.S.A, Inc.
Location: San Diego
Posted on: June 24, 2022

Job Description:

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.

Keywords: Tanabe Research Laboratories U.S.A, Inc., San Diego , Antibodies/ADC DMPK/T Lead (Senior Scientist/Principal Scientist), Other , San Diego, California

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