Staff Research Associate
Company: International Foodservice Manufacturers Associatio
Location: San Francisco
Posted on: November 6, 2024
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Job Description:
The UCSF Hair Analytical Laboratory (HAL) analyzes
antiretroviral, anti-tuberculosis (anti-TB), antibiotic, and
controlled substance concentrations in hair (but may include other
biological specimens such as urine, dried blood spot (DBS), whole
blood, plasma, serum, nail, saliva, etc.) in the context of HIV and
TB prevention and treatment studies using assays that are developed
and validated according to the Federal Drug Administration (FDA's)
guidelines for bioanalytical methods and the National Institute of
Health's (NIH's) Division of AIDS' (DAIDS) Clinical Pharmacology
Quality Assurance Program (CPQA). This position is responsible for
overseeing and maintaining high-quality regulatory functions in the
laboratory. This position will assist senior analysts and train and
mentor junior analysts to determine drug concentrations in samples
utilizing validated high-performance liquid chromatographic
(HPLC)-tandem mass spectrometric (LC/MS/MS) bioanalytical methods.
The purpose of this position is to design, develop, and execute a
variety of analytical methods to quantitate antiretroviral,
anti-TB, antibiotic drugs, controlled substances, and/or other
biomarkers using liquid chromatography-tandem mass spectrometry
(LC-MS/MS), primarily in hair samples (but may include other
biological specimens, such as urine, DBS, whole blood, plasma,
serum, nail, saliva, etc.), for pharmacokinetic, compliance, and
efficacy studies. Techniques may include, but not limited to,
protein precipitation, liquid-liquid extraction (LLE), and solid
phase extraction (SPE). The successful candidate will have some
knowledge and engage in analytical LC/MS/MS method development,
validation, and the assaying of clinical samples in compliance with
the Food and Drug Administration's (FDA's) Good Laboratory Practice
(GLP) and National Institute of Health's (NIH's Division of AIDS'
(DAIDS) Clinical Pharmacology Quality Assurance (CPQA) regulatory
guidelines. In addition, be required to prepare Standard Operating
Procedures (SOPs) and Analytical Validation Reports (AVR) for
submission to Clinical Pharmacology Quality Assurance (CPQA);
respond to inquiries from CPQA; train and mentor new staff members
after completing and understanding internal laboratory SOPs;
operate and calibrate analytical instruments; use and calibrate
micropipettes; prepare, analyze, run, and interpret data; and
thoroughly document in lab books, log books, and paperwork.
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Keywords: International Foodservice Manufacturers Associatio, Manteca , Staff Research Associate, Other , San Francisco, California
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