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Lead process development and scale-up of manufacturing processes production in a lab environment.
Design and develop processes for manufacturing using statistics-based experimentation and principles of process excellence.
Performs software installation and validations.
Leads process risk and validation master planning activities
Work with internal organizations and vendors to ensure regulatory and company compliance of manufacturing processes.
Involved in process development and validation activities for software, equipment, test method, and cleaning for reagent manufacturing. Work with equipment vendors to define, develop, implement and qualify process equipment.
Develop production procedures and product specifications.
Monitor the performance of processes and equipment and makes recommendations for continuous improvement.
Works on assignments with broadly defined objectives
Bachelor's or Master's Degree or University Degree or equivalent.
Typically 2+ years relevant experience for entry to this level.
Requires general proficiency with manufacturing methods and processes (Ex: mixing, filtering, purification), systems (Word and Excel), and analytical testing to accomplish the job.
Strong communication skills both verbal and written
Experience with Technical writing.
Experience in a Biological reagent manufacturing and process development setting.
Use of statistical techniques to design experiments and interpret results.
Utilization of One or more of the following: software validation, equipment qualification, process risk and validation master planning.
Strong familiarity with analytical test methods and data analysis.