JOB TITLE:

Development Associate (Molecular Biologist)

RESPONSIBLE TO:

Development Manager

JOB DUTIES:

  • Develop and analyze Enzyme Immunoassays to prepare for FDA De Novo and 510(k) submissions, optimize performances of immunoassays and interpret results.
  • Use in-depth knowledge of clinical analyzers (such as Roche COBAS C501, Beckman Coulter AU680, AU480, AU400, Siemens Viva-E and Hitachi 717) to develop, validate enzyme immunoassays and interpret their performance on clinical analyzer.
  • Evaluate new equipment and re-evaluate the existing equipment such as laboratory freezers and temperature incubators to ensure operability.
  • Prepare reports, manuscripts, and presentations for project updates to management.
  • Develop guidelines and protocols for new development experiments and procedures.
  • Perform literature research and hands-on experiments to answer FDA reviewers’ questions during De Novo or 510(k) approval submissions.
  • Investigate metabolic pathways of various drugs to determine suitable analytes for the new enzyme immunoassays for drugs-of-abuse and therapeutic drug monitoring.
  • Use physiological pharmacology knowledge to understand the metabolisms of drugs and design immunoassays with the knowledge.
  • Investigate the effectiveness and feasibility of research and development projects before they enter the development stage.
  • Help Production/Manufacturing and Quality Control teams with the new product launches.
  • Work with scientists from Immunology and Organic Chemistry research teams to share knowledge on Immunoassay Development.
  • Prepare various drugs and chemical compounds for cross-reactivity testing.
  • Perform cross-reactivity testing against enzyme immunoassays for 510(k) projects and customer requests.
  • Prepare the collected clinical urine and oral fluid samples for liquid chromatography-mass spectrometry or gas chromatography-mass spectrometry testing and data analysis of the results.
  • Handle maintenance of clinical analyzers and co-ordinate with out-of-company service teams for preventive maintenance/instrument reconditioning.

MINIMUM REQUIREMENTS:

  • Master’s degree or foreign equivalent degree in Molecular Biology, Biomedical Engineering, Biochemistry, or a related field required.
  • Academic coursework at graduate school level in physiological pharmacology required.
  • Demonstrated knowledge of drug metabolism and pharmacokinetic pathways in the human body required.

ADDITIONAL INFORMATION:

  • Employer’s Name: Lin-Zhi International, Inc.
  • Job site: Lin-Zhi International, Inc., 2945 Oakmead Village Court, Santa Clara, CA 95051
  • If you are interested in applying for this position, please mail resume with Job # ADM0263 to HR at: Lin-Zhi International, Inc., 2945 Oakmead Village Court, Santa Clara, CA 95051