Job Summary

We are seeking an experienced Research Analyst for our Safety Assessment site located in Mattawan, MI.

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.

Essential Functions:

• 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
• Independently perform laboratory support functions such as labeling and solution preparations
• Assist with maintaining study specific inventory of consumables with oversight
• Write both study and non-study deviations with minimal oversight
• Actively participate in process improvement initiatives with oversight
• Develop critical thinking, troubleshooting and time management skills aligned with needs of the operational area
• Assist in execution of routine sample analysis studies with oversight
• Assist in execution of method validation projects with oversight as needed
• Operate laboratory instruments with complete oversight
• Assist with data analysis in appropriate software for at least one analytical platform

Job Qualifications

Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:

• Minimum of a Bachelor’s degree (BA/BS) or equivalent experience. No previous work experience required
• 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
• Ability to wear proper PPE for the duration of the shift; which includes and is not limited to the following: Gloves, safety glasses, laboratory coat, cartridge respirator, dust/mist respirator, supplied air respirator, Tyvek suit, sleeve protectors.