• Develop processes for manufacturing reagents for automated cancer diagnostic assays.
• Devise experimental design for process characterization and optimization.
• Develop and implement process optimization and characterization.
• Develop necessary documentation.
• Interface with manufacturing in the transfer and scale up of reagents/assays for commercial sale.
• Serve as an instrumental team member for root cause investigations of customer reagent quality concerns and process improvements.

Position Requirements:

• M.S. or PhD in biochemistry or relevant life sciences degree.
• Experience with protein conjugation is required.
• Working knowledge of experimental design (DOE), statistical approaches and relevant software.
• Knowledge of documentation and SOP production requirements in FDA regulated environments is required.
• Prior supervisory experience would be a plus.
• Experience in a cGMP industrial environment highly desired.

Personal Characteristics:

• Ability to work in a fast paced and dynamic environment.
• Excellent cross-functional team leadership and participation skills.
• Strong analytical, problem solving and trouble shooting skills.
• Highly organized and detail-oriented.
• Results and goals oriented.
• Excellent written and oral communications.