Development Associate (Molecular Biologist)
- 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.
- 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.
- 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