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For your reference, we have included the original job posting below.
Supervisor, Manufacturing - Central Services
Job Number:
38399859
Company Name:
Alexion Pharmaceuticals
Job Location:
Smithfield, RI US
Job Category:
Healthcare & Medical
Supervisor, Manufacturing - Central Services
Supervisor, Manufacturing - Central Services
Department: Manufacturing Location: Smithfield RI Job Code: 422
Description
AlexionRIManufacturing Facility Job Description
Department: ARIMF Technical Operations Position: Manufactuirng Supervisor, Central Services Reports to: Central Services Manger
Position Overview:
Provide daily supervision for the clinical and commercial production areas to meet area productivity and timing goals. This includes process planning activities, setting operator work schedules, coordinating interactions and services from other groups internal and external to the production area, and assigning work tasks. Additional responsibilities will be: the hiring, development and training of operators, the authoring of SOP’s & production batch records, in addition to the review of executed production batch records.
Responsibilities: Responsible for activities required for successful and compliant cGMP operation of the clinical and commercial production area, which operates on a 7 day per week schedule. These activities include: Ensuring batch production activities follow all documentation and standard operating procedures. Setting process execution and operator work assignment schedules. Responsible for cGMP compliance, ensuring that all production equipment is ready to support production and production processes meet batch record requirements. Authors and revises standard operating procedures and batch records as required. Trains operators in standard operating procedures. Provides production review of batch documentation for completeness and accuracy. On the floor support during agency inspections. Addresses all issues raised during batch documentation review and provides appropriate and timely responses. Along with safety and maintenance problems, communicates status of operations in a timely manner to upper management Measure and appraise operator performance against job duties and objectives.
Requirements: BA/BS in Biology, Chemistry, or related discipline, or equivalent experience. Minimum of 2 years of supervisory experience with at least 5 – 7 years total in a biologics facility with mammalian cell culture production. Familiarity with regulatory inspection process. Demonstrated high level of theoretical understanding and technical proficiency of operations within functional area. Must be able to write effectively as demonstrated through authorship of batch records, standard operating procedures and technical reports. Must be able to follow detailed instructions and record information clearly and accurately. Must possess excellent communication and interpersonal skills. Demonstrated knowledge and experience in aseptic processing techniques. Must be able to apply technical and operational experience to perform complex problem solving activities.
