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Responsibilities:

• Independently craft experimental approaches to assess viability and feasibility of new reagents and assays
• Prepare and coordinate the preparation of technical reports, summaries, protocols, and analyses of R&D projects.
• Maintain strong understanding of state-of-the-art science and technology development in the industry.
• Perform data analysis and reporting of flow cytometry clinical samples across a variety of cytometry assays.
• Provide technical expertise, leadership and support for flow cytometry operations for assay/result troubleshooting.
• Participate in streamlining processes related to PIRs and CAPAs to reach a rapid and effective conclusion.
• Plan/participate in the sustaining projects, lead troubleshooting and risk assessment activities.
• Effectively coordinate with other functional areas associated with the R&D activities, including Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, Business Development, etc.
• Participate in interactions with regulatory agencies. Provide technical input into safety and regulatory interactions.
• Write and review standard operating procedures and policies for the department.

Requirements:

• Minimum of a Master's degree in Immunology or related biological science field with at least 3 years of relevant experience or Ph.D. with at least some relevant industry experience.
• Minimum of 5 years' related experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
• Experience with sample prep and experiment design for multi-parameter flow cytometry applications.
• Experience training bench-level personnel and leading projects.
• Extensive hands-on experience operating and troubleshooting flow cytometers.
• Experience in IVD product development is desired but not required.