Job description – Manufacturing Supervisor

The Manufacturing Supervisor is responsible for leading various manufacturing activities related to the start-up and GMP production of a number of novel cellular products, in compliance with regulatory agencies and associated guidelines.

 

DUTIES AND RESPONSIBILITIES:

The Application Administrator position is responsible for the management and/or contribution to all aspects of MasterControl projects involving the analysis, configuration, integration and maintenance of MasterControl systems and the system’s interfaces with other corporate enterprise systems. The Administrator will collaborate and be a key stakeholder for projects and daily deliverables for the companies’ Document Control, Quality Assurance, and IT departments.

  • Oversees manufacturing personnel in equipment setup, equipment operation, and processes in accordance with cGMPs, Cognate Quality System, and process documents. Conducts and/or schedules training for new employees including media fills. Schedules personnel to support all production related activities.
  • Provides assistance to management in the revision and/or writing of process documents to assure accuracy and completeness. This includes but is not limited to reviewing BPRs and associated documentation for accuracy, compliance, and presence of all verification signatures.
  • Assures employees understand duties, responsibilities, policies, and procedures.
  • Oversees training of employees.
  • Advises management on personnel management functions.
  • Leads and implements continuous improvement activities and assists with projects as assigned.
  • Enforces adherence to regulatory guidelines and Cognate internal policies.
  • Takes part in Technology Transfer. May collect, analyze and summarize information and trends.
  • Lead, mentor, and develop direct reports.
  • All other duties as assigned.

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • BS or AS with a minimum of 3 years applicable experience
  • Exhibits exceptional leadership qualities
  • Two years of leadership experience preferred
  • Must be detail oriented and have excellent organizational skills
  • Must possess effective written and oral communication skills
  • Must display a high degree of professionalism and confidentiality

 

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