Manufacturing Operations Manager

3 weeks ago


Melville, New York, United States Kedrion Biopharma Inc. Full time
Job Summary

This is an exciting opportunity to join Kedrion Biopharma Inc. as a Manufacturing Supervisor. As a key member of our team, you will be responsible for leading a team of technicians and operators in a fast-paced plasma manufacturing environment.

Main Responsibilities
  • Leadership and Direction: Provide guidance and mentorship to team members to ensure they have the skills and knowledge needed to perform their duties effectively.
  • Scheduling and Workload Management: Schedule workload for the shift and ensure a smooth transition between shifts to maintain productivity and efficiency.
  • Incident Reporting and Analysis: Investigate and report incidents, and participate in Failure Mode Analysis to identify and implement corrective actions.
  • Quality and Compliance: Ensure all production materials and PPE are available as required, and that employees are trained and comply with cGMPs and SOPs.
  • Performance Management: Manage the performance of direct reports, including periodic reviews, coaching, and disciplinary action if necessary.
  • Regulatory Compliance: Ensure compliance with all cGMP requirements, including batch record review, and regulations impacting manufacturing operations.
  • Additional Responsibilities: Participate in company-wide safety teams, conduct accident investigations, and develop SOPs and specifications as required.
Requirements
  • Education: Bachelor's Degree in Science, Engineering, or related field.
  • Experience: Five years of experience in a manufacturing environment, with a minimum of three years in a supervisory role.
  • Skills: Knowledge of Fractionation Process, Microsoft Office Suite, Microsoft Project, and Database management.
  • Regulatory Knowledge: Extensive knowledge of global cGMPs, regulations, and validation requirements.


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