International Foodservice Manufacturers Association
Staff Research Associate
International Foodservice Manufacturers Association, San Francisco, California, United States, 94199
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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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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