Job Abstract

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 (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.

The final salary and offer components are subject to additional approvals based on UC policy.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)

Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

One year of Laboratory Data Management System (LDMS) experience
Knowledge of the basic principles in chemistry
Strong lab book preparation and documentation skills
Prior knowledge in the US FDA Good Laboratory Practices (GLP) and the NIH DAIDS Clinical Pharmacology Quality Assurance (CPQA) regulations

One year related scientific techniques and procedures as learned from academic laboratory or field experimental experience, especially utilizing LC-MS/MS systems (preferably Micromass Quattro Ultima (MassLynx software), Sciex API 5000 (Analyst software), and/or Agilent 6495 (MassHunter software) and HPLC systems
BA/BS in a related science including one year of recent/directly related work experience following degree completion, utilizing the techniques/methods required by the position; or an equivalent combination of education and experience
Demonstrate reliability, organizational skills, attention to detail, and record keeping abilities based on prior experience
Outstanding communication skills
Strong basic laboratory techniques, such as micropipetting; measuring solutions using volumetric flasks and graduated cylinders; making reagents, mobile phases, and standard solutions; using centrifuges, vortexers, and other equipment in an analytical laboratory
Computer software skills (MS Word, Excel and PowerPoint)

Search Terms: Research Associate, Staff, Quality Assurance, Clinical, Associate

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