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In-depth knowledge of product development, extensive experience in scale up, process improvements, validation and transfer of production processes to Operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment in determining the scope and timing of transfer activities. Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Responsible for improving process efficiency and product quality. Determines methods and procedures on new assignments.
Job Responsibility:
Represents Reagent operations in new product teams as the core team member
Transfers products and processes into manufacturing following the Global Product Development System
Develops strategies and carries out plans to stabilize and reduce production cost of new products
Generates manufacturing plan based on the product requirements and the anticipated manufacturing resources needed to produce and ship the new product
Prepares and submits SOP’s, WI’s, BOM’s, routings and standard costing for new product into SAP
Provides floor support
Independently performing root cause analysis for product complaints through experiments involving flow cytometry/applications and production process evaluations including physical property or analytical data analysis
Responsible for the timely documentation of the results and conclusions
Evaluates failures, writes Variance Reports (VR's), presents recommendations to Material Review Board
Analyzes and solves complex and challenging problems in Production and Quality Control
Provides support by providing flow cytometry expertise to experimental strategy, problem characterization, data acquisition and analysis