Research Associate, Product Transfer

What You’ll Do

• Work independently and with team members to perform routine and specialized laboratory procedures and operate a wide range of instruments.
• Apply your laboratory skills and experience to generate high quality data in support of a diversity of projects, which will include both immunoassay development and validation as well as testing and analysis of clinical samples using commercial kits.
• Apply technical knowledge of immunoassays, laboratory skills, creative thinking, and aptitude towards instrumentation to troubleshoot assay issues in Development, Pilot and Manufacturing.
• Experience recommending how to correct component or assay issues, primarily through formulation optimization and lab techniques.
• Collaborate with Manufacturing, Assay Development, Engineering, Technical Support, and Quality Control groups to support resolution of complex issues.
• Generate high quality data under tight deadlines.
• Support continuous improvement efforts, by evaluating potential process changes in manufacturing and quality control.
• Implement process improvements in manufacturing and quality control, optimizing processes to improve repeatability and reproducibility.
• Support document updates, revisions, change controls, CAPAs, SOPs, deviations, etc.
• Support Manufacturing, Quality Control and Assay Development by shadowing the process and providing beneficial feedback and knowledge on the process.
• Support and help drive implementation of best practices and process improvements.

What We’ll Expect From You :

• BS in Chemistry, Biochemistry, Engineering, or Life Science (with 2+ years relevant experience).
• Experience with preparation and handling of complex and sensitive bio-reagents.
• Experience in immunoassay product development strongly desired, including reagent development and optimization, assay protocol optimization, migration of manual assays to automated instrumentation, specifications development, statistical methods, verification and validation protocol writing and execution, conformance with design control regulations.
• Experience with development and / or validation of assay products is a plus.
• Knowledge of chemistry and raw materials a plus.
• Must be detail oriented with excellent organizational, record keeping, and communication skills.
• Demonstrated ability to support multiple projects under aggressive timelines.
• Self-motivated with a strong work ethic.
• Ability to collaborate cross-functionally.
• Must be proactive and ensure all work meets company compliance standards.
• Document all activities in accordance good documentation practices.
• BS in Chemistry, Biochemistry, Engineering, or Life Science (with 2+ years relevant experience).
• Experience with preparation and handling of complex and sensitive bio-reagents.
Hace más de 30 días