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Assist Manager, with overseeing the day-to-day operations of Serum Bulk Manufacturing and Monoclonal Production departments with a high degree of attention to detail to achieve quality, compliance, stability and predictability in manufacturing. These processes include, but are not limited to, training and developing of employees, coordinating and scheduling operations, cleaning and sterilization of containers used in production, processing raw material, dilution of solutions/diluents, dilution of final products, intermediate filtrations, and final filtrations. Within in the Monoclonal department, processes include, maintaining Hybridoma cell cultures according to established procedures. Performs subsequent testing and processing of culture supernates to intermediate material for further manufacturing use. Performs certain production tasks in a cleanroom environment in compliance with Good Manufacturing Practices and Good Documentation Practices.
Job Responsibility:
Assist Manager, with overseeing the day-to-day operations of Serum Bulk Manufacturing and Monoclonal Production departments
Provides Guidance to Serum Bulk Manufacturing and Monoclonal Production team members for daily manufacturing operations
Trains new Serum Bulk Manufacturing and Monoclonal Production team members and ensure that all team members maintain up to date training records
Performs evaluations and team development
Helps to maintain department morale and employee motivation in a positive work environment
Monitors and maintains inventory of required supplies, components, and raw material and ensures that the teams have materials needed for their processes
Assists in scheduling of special projects and validation activities within the department
Ensures calculations are correct for products
Performs review of all records completed by teams, as well as works in MasterControl performing updates and reviews
Works on Change Controls and other qualty records
Performs daily walk throughs of the areas to ensure that they are being maintained and follows the Continuous Improvement model
Performs other duties and responsibilities as assigned
Requirements:
Bachelor of Science Degree in related field required and/or equivalent type of experience required
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to work with mathematical concepts, such as, probability and statistical interference, and fundamentals of plane, solid geometry and trigonometry
Ability to apply concepts, such as fractions, percentages, ratios and proportions to practical situations
Ability to apply common sense understanding to carry our instructions furnished in written, oral and diagram form
Ability to deal with problems involving several concrete variables in standardized situations