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
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
- 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
- Independently and effectively troubleshoots complex
- 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
- 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
- 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
- Strong written, verbal, organizational and interpersonal
- Ability to change tasks quickly and still maintain
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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