Staff Research Associate

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 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.

Responsibilities

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%.

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

55
Yes

• Design, develop, and execute a variety of analytical methods to detect drugs (and/or other biomarkers) in biological matrices, particularly human hair (but not limited to urine, dried blood spot (DBS), whole blood, plasma, serum, nail, saliva, etc.) for high-performance liquid chromatography (HPLC), tandem mass spectrometry (LC/MS/MS). Techniques may include (but not limited) to protein precipitation, liquid-liquid extraction (LLE) and solid phase extraction (SPE).
• Prepare hair samples (but may also include other biological specimens, such as DBS, urine, plasma, serum, whole blood, nail, saliva, etc.) to determine drug concentrations, which involves measuring and cutting hair samples into very small pieces, weigh and process the sample to run and analyze on LC-MS/MS.
• Other responsibilities during sample preparation include but not limited to pipetting and transferring microliter volumes of solutions following standard operating procedures (SOPs); weighing milligram amounts of chemicals using a microbalance; preparing standard solutions using volumetric flasks, reagents, mobile phases, and solvent mixtures; comparing standard solutions utilizing HPLC-ultraviolet detector (HPLC-UV); documenting daily tasks into laboratory notebooks and log books in accordance with SOPs; and filing paperwork and lab books into the appropriate locked drawers.
• Operation of the HPLC-UV and LC-MS/MS equipment including preparing and loading batch files into the system; loading samples into the autosampler; choosing appropriate method, mobile phase(s), needle wash, and analytical column according to the analytical procedure (AP) of the compound being measured; calculating/interpreting the generated data; and summarizing the data into Excel tables as final data to send to sponsors and include in analytical reports.
• Compile final data for studies into tables for submission to study principal investigators (PIs), study coordinators, and management.
• Troubleshoot the MS/MS (Micromass Quattro Ultima, Sciex 7500+ QTRAP, and Agilent 6495 systems) and HPLC systems and calibrate these systems every other month.
• Train junior staff members in various laboratory techniques and procedures after proficiency following and executing the appropriate laboratory SOP and analytical procedure for methods and equipment.

20
Yes

• Validate and prepare SOPs and analytical validation reports (AVRs) for analytical methods in compliance with the US Food and Drug Administration's (FDA's) and the National Institutes of Health's (NIH's) Division of AIDS' (DAIDS) supported Clinical Pharmacology Quality Assurance program (CPQA) regulatory guidelines for CPQA submission and respond to CPQA inquiries about the AVR and SOP reports.

15
Yes

• Share responsibilities for lab management tasks as needed, but not limited to, such as washing and organizing glassware; re-stocking and re-organizing supplies; calibrating the microbalances, micropipettes, repeater pipette, and equipment; maintaining and troubleshooting equipment with the assistance of senior staff members and management; and collecting positive incurred quality control samples; checking, printing, and filing and changing iMonnit freezer/refrigerator charts.
• Utilize laboratory information management system (LDMS) for scanning and logging in samples received by the laboratory for specimen tracking and inventory storage, update LDMS inquiries from clinical laboratories, and contact the appropriate personnel for discrepancy queries.

10
Yes

• Assist and prepare laboratory SOPs in compliance with the FDA and CPQA regulatory guidelines; writing, editing, and/or contributing towards articles and papers for submission to publications in scientific journals, presentations at group meetings, and posters for meetings, conferences, or symposiums.

100%


(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

Qualifications

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