Tanvex Biopharma is a biologic pharmaceutical product development and manufacturing organization aiming to provide high-quality, value-added capabilities to accelerate the introduction of biologic therapeutics to the global market. We currently have an exciting opportunity for a Associate Scientist in our Bioassay Development group at our location in San Diego, CA.
SUMMARY:
The Associate Scientist, Analytical Bioassay is responsible for biological characterization of biologics drug candidates including method development, method qualifications, method transfer & training, and routine non-GMP sample testing. Designs a set of experiments that contribute to project objectives. Suggests new methods and technologies to increase understanding of complex biotherapeutics. Interacts with other functional groups on significant technical matters.
JOB RESPONSIBILITIES:
Essential:
- Effective application of scientific principles for the detailed characterization of biotherapeutics. Includes antigen/receptor binding assays, functional biological cell-based assays (i.e. cell adhesion, proliferation, and death), and impurity profile analysis by qPCR and/or ELISA.
- Designs, implements, and conducts a set of scientific experiments which contribute to project objectives. Performs trouble-shooting of assays.
- Collaborates with cell culture, purification, formulation, QC, and manufacturing groups for achievement of project objectives.
- Designs and performs a set of experiments applying a variety of biochemical, biological, and immunological techniques to support process development, formulation development and quality control. Solid understanding of the underlying principles of the techniques.
- Suggests new processes and technologies to increase understanding of complex biotherapeutics. Proactively identifies assay issues and suggests solutions.
- Consistently demonstrates scientific soundness in the laboratory.
Supplementary:
- Serves as a technical resource in assay transfer from analytical development to quality control including method qualification, SOP drafting, and discrepancy resolution. Provides technical troubleshooting. Applies GMP knowledge when needed to ensure quality standards are met.
- Advanced communicator of ideas, project goals and results within the analytical group.
- Interacts with other functional groups as a contact on significant technical matters.
- Authors internal reports at appropriate milestones including assay qualification reports, development reports, and standard operating procedures.
JOB REQUIREMENTS:
Education:
- Bachelor’s or advanced degree in biochemistry, molecular and cell biology, or related scientific discipline.
- BS with 5 years of experience or MS with 3 years of experience in bioassay development within a pharmaceutical development group.
Knowledge, skills, and abilities:
- Proficient in mammalian cell culture for bioassay development and testing.
- Proficient in scientific data analysis with a variety of technical software.
- Understand protein function and bioassay methodologies which applies to the selection of the appropriate analytical tools and the efficient design of characterization development studies.
- Advanced communicator of ideas, experiment goals, and results.
- Capable of working effectively in teams.
- Understand assay development requirements for implementation in a quality control environment.
- Design and execute experiments with increasing independence. Capable of complex data interpretation with guidance.
- Some knowledge of ICH guidelines for assay validation.
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