Staff Research Associate

UCSF•San Francisco, CA

1d•Onsite

About The Position

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 HAL Staff Research Associate II 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, the candidate will also 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 successfully completing and understanding internal laboratory SOPs; operate, calibrate, and troubleshoot analytical instruments; use and calibrate micropipettes; prepare, analyze, run, and interpret data; and thoroughly document in lab books, log books, and paperwork.

Requirements

Knowledge of analytical LC/MS/MS method development, validation, and assaying of clinical samples.
Understanding of 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.
Ability to prepare Standard Operating Procedures (SOPs) and Analytical Validation Reports (AVR).
Ability to respond to inquiries from CPQA.
Ability to train and mentor new staff members.
Ability to operate, calibrate, and troubleshoot analytical instruments.
Ability to use and calibrate micropipettes.
Ability to prepare, analyze, run, and interpret data.
Ability to thoroughly document in lab books, log books, and paperwork.

Nice To Haves

Experience with techniques including protein precipitation, liquid-liquid extraction (LLE), and solid phase extraction (SPE).

Responsibilities

Overseeing and maintaining high quality regulatory functions in the laboratory.
Assisting senior analysts.
Training and mentoring junior analysts.
Determining drug concentrations in samples utilizing validated high-performance liquid chromatographic (HPLC)-tandem mass spectrometric (LC/MS/MS) bioanalytical methods.
Designing, developing, and executing 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.
Engaging in analytical LC/MS/MS method development, validation, and the assaying of clinical samples in compliance with regulatory guidelines.
Preparing Standard Operating Procedures (SOPs) and Analytical Validation Reports (AVR) for submission.
Responding to inquiries from CPQA.
Training and mentoring new staff members.
Operating, calibrating, and troubleshooting analytical instruments.
Using and calibrating micropipettes.
Preparing, analyzing, running, and interpreting data.
Thoroughly documenting in lab books, log books, and paperwork.