Only the job description changed.
| Previous Job Description | Current Job Description | ||||
|---|---|---|---|---|---|
| n | 1 | Job Description: | n | 1 | The UCSF Hair Analytical Laboratory (HAL) analyzes antiretroviral, anti-tuberculosis (anti-TB), anti |
| > | biotic, 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 contex | ||||
| > | t of HIV and TB prevention and treatment studies using assays that are developed and validated accor | ||||
| > | ding to the Federal Drug Administration (FDA’s) guidelines for bioanalytical methods and the Nationa | ||||
| > | l Institute of Health’s (NIH’s) Division of AIDS’ (DAIDS) Clinical Pharmacology Quality Assurance Pr | ||||
| > | ogram (CPQA). This position is responsible for overseeing and maintaining high quality regulatory fu | ||||
| > | nctions in the laboratory. | ||||
| 2 | The UCSF Hair Analytical Laboratory (HAL) analyzes antiretroviral, anti-tuberculosis (anti-TB), anti | ||||
| > | biotic, 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 contex | ||||
| > | t of HIV and TB prevention and treatment studies using assays that are developed and validated accor | ||||
| > | ding to the Federal Drug Administration (FDA’s) guidelines for bioanalytical methods and the Nationa | ||||
| > | l Institute of Health’s (NIH’s) Division of AIDS’ (DAIDS) Clinical Pharmacology Quality Assurance Pr | ||||
| > | ogram (CPQA). This position is responsible for overseeing and maintaining high quality regulatory fu | ||||
| > | nctions 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 validate | ||||
| > | d 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 met | ||||
| > | hods to quantitate antiretroviral, anti-TB, antibiotic drugs, controlled substances, and/or other bi | ||||
| > | omarkers 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, s | ||||
| > | aliva, 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 develop | ||||
| > | ment, validation, and the assaying of clinical samples in compliance with the Food and Drug Administ | ||||
| > | ration’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 V | ||||
| > | alidation 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 understan | ||||
| > | ding internal laboratory SOPs; operate, calibrate, and troubleshoot analytical instruments; use and | ||||
| > | calibrate micropipettes; prepare, analyze, run, and interpret data; and thoroughly document in lab b | ||||
| > | ooks, log books, and paperwork. | ||||
| 3 | 2 | ||||
| t | 4 | Qualifications: | t | 3 | This HAL Staff Research Associate II position will assist senior analysts and train and mentor juni |
| > | or analysts to determine drug concentrations in samples utilizing validated high-performance liquid | ||||
| > | chromatographic (HPLC)-tandem mass spectrometric (LC/MS/MS) bioanalytical methods. | ||||
| 5 | Required Qualifications: • BA/BS in a related science and one or more years of recent, directly rela | 4 | |||
| > | ted work experience utilizing the techniques or methods required by the position; or an equivalent c | ||||
| > | ombination of education and experience • Experience preparing a linear standard curve with quality c | ||||
| > | ontrols 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 scientifi | ||||
| > | c techniques and procedures, including LC-MS/MS systems (preferably Micromass Quattro Ultima [MassLy | ||||
| > | nx 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 a | ||||
| > | nd graduated cylinders; preparing reagents, mobile phases, and standard solutions; and using centrif | ||||
| > | uges, vortexers, and other analytical laboratory equipment • Proficiency in computer software (MS Wo | ||||
| > | rd, Excel, and PowerPoint) Preferred Qualifications: • Knowledge of the basic principles in chemistr | ||||
| > | y • 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) an | ||||
| > | d NIH DAIDS Clinical Pharmacology Quality Assurance (CPQA) regulations | ||||
| 5 | 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, e | ||||
| > | tc.), 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 su | ||||
| > | ccessful candidate will have some knowledge and engage in analytical LC/MS/MS method development, va | ||||
| > | lidation, 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 cand | ||||
| > | idate will also be required to prepare Standard Operating Procedures (SOPs) and Analytical Validatio | ||||
| > | n Reports (AVR) for submission to Clinical Pharmacology Quality Assurance (CPQA); respond to inquiri | ||||
| > | es from CPQA; train and mentor new staff members after successfully completing and understanding int | ||||
| > | ernal laboratory SOPs; operate, calibrate, and troubleshoot analytical instruments; use and calibrat | ||||
| > | e micropipettes; prepare, analyze, run, and interpret data; and thoroughly document in lab books, lo | ||||
| > | g books, and paperwork. | ||||