Research Analyst III, Bioanalytical Chemistry 1
About The Position
A Research Analyst III is responsible for 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.
Requirements
- Bachelor's degree (BA/BS) or equivalent experience. A minimum of 2 years of working experience in a technical laboratory role
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Ability to communicate verbally and in writing at all levels inside and outside the organization
- Basic familiarity with Microsoft Office Suite
- Computer skills, commensurate with Essential Functions, including the 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
- Ability to work under specific time constraints
Responsibilities
- Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
- Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
- Assist with laboratory maintenance functions
- Assists with laboratory support functions such as labeling and solution preparations
- Independently maintain study specific inventory of consumables
- Independently write both study and non-study deviations
- Independently participate in process improvement initiatives as needed
- Develop and maintain critical thinking, troubleshooting and time management skills aligned with needs of the operational area
- Independently execute routine studies
- Independently execute assay and/or method validation projects
- Operate laboratory instruments with minimal oversight
- Independently perform data analysis in appropriate software for a majority of platforms within an operational area
- Assist with minimal oversight the completion of laboratory investigations, assay troubleshooting and quality observations
- Independently prepare paperwork for routine production work
- Assist with training of new staff members for minimal functions as needed
- Performs all other related duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Ambulatory Health Care Services
Number of Employees
5,001-10,000 employees
