Research Analyst II, Discovery Bioanalytical 1

Job Summary

Bioanalytical Chemistry supports the evaluations of test compounds by providing bioanalytical quantitative analysis of drug in body fluids and tissues from non-regulated and regulated studies including preclinical safety evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials. Staff participate in the development and validation of quantitative LC/MS/MS methodology, sample analysis, and interpretation and reporting of data utilizing validated hardware and software systems. This includes the development of sample extraction techniques, rapid LC separations, and employment of laboratory robotics to enhance delivery time of bioanalytical data. Staff are also knowledgeable in the application of GxP’s and applicable SOPs, along with adhering to study protocols to accurately document methods, procedures, and results for inclusion into study reports and regulatory documents.

Job Qualifications

The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:

Operates applicable laboratory equipment, including any respective software applications, to prepare samples and/or solutions and quantitate sample runs. •    Preparation of sample out of different biological matrices for analysis per applicable analytical methods and SOPs. •    Communicates effectively with supervisors, colleagues, Principal Investigators, and Study Directors. •    Demonstrates commitment to quality. •    Effectively works in a team and demonstrates a commitment to achieving company goals. •    Efficiently prioritizes assigned daily workload and uses time productively •    Adheres to safety procedures at all times. •    Reads, understands, and follows SOPs, safety requirements, regulatory guidelines, and company policies. •    Consistently follows established methods for isolating and quantifying compounds for routine sample analysis utilizing standard analytical and immunology platforms. •    Possesses the ability to execute validation studies under direction. •    Consistently documents all procedures and materials in compliance with GxP standards. •    Operates applicable laboratory instruments including their respective software applications to prepare sample and quantitate sample runs. •    Possesses the ability to learn and utilize software applications. •    Assists in the completion of laboratory investigations, assay troubleshooting, and quality observations, as needed.

Job Qualifications Knowledge, Experience, Skills and Abilities required to accomplish the essential functions include, but are not limited to: •    BS/BA in relevant field or equivalent experience. A minimum of 1 year of working experience in a technical laboratory role •    Experience with bioanalytical extraction procedures and basic operation of LC-MS/MS  •    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above •    Computer skills, commensurate with Essential Functions and including ability to learn a validated system. •    Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended shifts and/or extra shifts, sometimes on short notice. •    Basic familiarity with Microsoft Office Suite. •    Ability to work under specific time constraints •    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

The pay range for this position is $25/hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.