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Position Overview

The QC Senior Analyst, Analytical Methods will support critical analytical method implementation workstreams in support of the facility start-up plan. These workstreams include analytical instrument qualification, critical reagent management, execution of technical protocols, and supporting the implementation of programs and procedures in a new Quality Control laboratory located in Durham, North Carolina. The work schedule for this position will be based on the manufacturing production schedule and will primarily be split shift (12pm - 8pm) with the possibility of working weekends when needed.

Primary Responsibilities:

• Maintain and operate analytical instrumentation for flow cytometry and other bioassays
• Analyze data; interpretation of data within given parameters
• Investigate out of specification or unexpected results and study outcomes
• Escalate and assist in the resolution of complex issues
• Independently develop, author, and execute protocols, reports and other related documents
• Communicate effectively with peers, and demonstrate collaboration across different functions
• Support the implementation and execution of training programs and processes for less experienced QC Analysts
• Draft and review technical documents

Qualifications:

• Bachelor’s degree required, preferably in a life science discipline with 3-4 years relevant experience
• Advanced hands-on experience with various analytical techniques primarily flow cytometry
• Scientific knowledge and direct experience with analytical method transfer requirements and processes
• Advanced technical writing and problem-solving ability
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.
• Advanced ability to communicate effectively with peers, department management and cross-functional peers