Description

You will perform analytical testing and maintain laboratory compliance within a GMP environment.

Responsibilities

• Conduct analytical testing of patient samples, stability samples, controls, and reagent qualification using ELISA, Flow Cytometry, and PCR.
• Troubleshoot instrumentation and established test methods.
• Write and execute protocols, reports, and SOPs.
• Evaluate new equipment for purchase and manage installations and qualifications.
• Perform assay reviews and assist in training QC staff.

Required Skills

• 5+ years of experience in a laboratory or QC setting.
• Proficiency in ELISA, Flow Cytometry, and PCR.
• Working knowledge of current Good Manufacturing Practices (cGMPs).
• Experience performing non-routine analysis of raw materials, intermediates, and finished products.
• Ability to maintain laboratory compliance and perform assay reviews.
• Proficiency with Microsoft Office software.
• Bachelor's degree.

Key Skills

Education

Bachelor's degree