Staff Research Associate

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.
 

DUTIES & ESSENTIAL JOB FUNCTIONS

Identify the functions or tasks that employees in the job perform. The essential functions should state the purpose of the work and the results to be accomplished, rather than how the function is performed. Of the tasks listed, what percentage of time is devoted to each? The more time employees spend on a function, the more likely it is that the function is essential. Generally, include those functions that account for 10% or more of the work, i.e., key items that contribute significantly to the achievement of the job. The functions should add up to 100%.

Required Qualifications:

• BA/BS in a related science and one or more years of recent, directly related work experience utilizing the techniques or methods required by the position; or an equivalent combination of education and experience
• Experience preparing a linear standard curve with quality controls to process and quantitate unknown drug concentrations in biological matrices
• At least one year of industry work experience or equivalent graduate research experience using relevant scientific techniques and procedures, including LC-MS/MS systems (preferably Micromass Quattro Ultima [MassLynx software], Sciex 7500+ QTRAP [Sciex OS software], and/or Agilent 6495 [MassHunter software]) for small molecule quantitation using standard calibrators and quality controls, as well as HPLC systems and related troubleshooting
• Demonstrated reliability, organizational skills, attention to detail, and record-keeping abilities based on prior experience
• Outstanding communication skills
• Strong basic laboratory techniques, including micropipetting; measuring solutions using volumetric flasks and graduated cylinders; preparing reagents, mobile phases, and standard solutions; and using centrifuges, vortexers, and other analytical laboratory equipment
• Proficiency in computer software (MS Word, Excel, and PowerPoint)
 

Preferred Qualifications:

• Knowledge of the basic principles in chemistry
• Strong lab notebook preparation and documentation skills
• At least one year of Laboratory Data Management System (LDMS) experience
• Prior knowledge of U.S. FDA Good Laboratory Practices (GLP) and NIH DAIDS Clinical Pharmacology Quality Assurance (CPQA) regulations