Method Development Scientist LBA- Senior Associate Scientist

Charles River Laboratories•Mattawan, MI

27d

About The Position

Biomarkers (and Investigative Pathology) personnel are responsible for: The development, performance, and support of biomarkers and flow cytometry-based assays. Assisting in sample analysis for both the support of internal studies as well as external client-based studies in a GLP compliant environment. Including, but not limited to cytokine, hormone, renal, cardiovascular, osteo, complement, metabolic, and inflammatory markers.

Requirements

Bachelor's degree (BA/BS) with 5-7 years of relevant working experience. Master's degree (MS) with 1-2 years of relevant work experience. Doctorate degree (PhD) with no experience
Experience with micropipetting (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

Nice To Haves

Experience building assays, assay development (Preferred)
Elisa and Luminex experience (Preferred)
Flow Cytometry experience (Preferred)

Responsibilities

Efficiently perform and document all procedure, materials, and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
Actively communicate and collaborate across operational areas in order to adhere to timelines and produce quality data
Assist with the completion of laboratory investigations, assay troubleshooting, quality observations, and problem solving of technical and/or regulatory issues with oversight
Effectively develop and validate quantitative/qualitative methods/procedure with limited complexity/scope in one operational area with minimal oversight
Perform data analysis in appropriate software for at least one analytical platform with minimal oversight
Operate laboratory instruments including their respective software applications for 1-2 analytical platforms with minimal oversight
Develop critical thinking, troubleshooting and time management skills aligned with the needs of operational area
Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
Develop ability to recognize method and/or data issues and communicate them to management to minimize study impact with minimal oversite
Prepare summary of method development data with minimal oversight
Write both study and non-study deviations with minimal oversite
Develop knowledge of regulatory and GXP requirements, industry standards and company SOPs within one operational area
Assist in leading the lab staff in the completion of method validation studies with oversight
Performs all other related duties as assigned