Scientist 1- Analytical

Company: Charles River Laboratories
Location: Shrewsbury
Posted on: June 24, 2022

Job Description:

Basic SummaryAssist in the development, execution and oversight of methods related to the testing of biotherapeutics using analytical instrumentation and compendial methodologies following USP and EP Guidelines. May be responsible for method feasibility, method development, method optimization, method transfers, method verifications, method qualifications, method validations and routine testing under cGMP environments. Additionally, will be responsible for client interaction, interpretation and reporting of data of assigned research projects. ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform and troubleshoot laboratory experiments, tests, and procedures within accepted regulatory compliance for the analysis of biotherapeutics through use of analytical instrumentation and methodologies in alignment with guidance as put forth by USP and EP.
• Ensure departmental compliance to USP and EP guidelines through frequent method review and optimization of general protocols.
• Provide scientific oversight of the routine performance of USP and EP methods as well as other basic laboratory assays such as the following, ensuring a high degree of reliability, efficiency, and accuracy:
• Appearance
• Endotoxin
• Karl Fisher
• Osmolality
• pH
• Closed Container Integrity Testing
• Extractable Volume
• Reconstitution Time
• Sub-Visible Particle (HIAC)
• BCA
• Review, interpret, analyze, evaluate, integrate, and present experimental data with the assistance of senior technical staff as appropriate.
• Perform tabulation and statistical analyses of study data, as required.

Keywords: Charles River Laboratories, Worcester , Scientist 1- Analytical, Other , Shrewsbury, Massachusetts