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Sr. Manager Lyophilization

Sr. Manager Lyophilization

Plan, execute and troubleshoot technical issues with the freeze dryers and the automated cycles associated with lyophilisation. Supports corporate projects: Lean Six Sigma and Compliance initiative.

Customers – Tours; screening projects; bids; work with New Business Development. Provide technical support to customers. Provide technical assistance with lyophilisation process development /optimization.

  • Accountable for ensuring cGMPs compliance of manufacturing operations to include operating procedures specifically to the operation of the freeze dryers and building utility systems.
  • Lead, plan, manage, and coordinate activities necessary to provide lyophilisation support to the Steriles operations.
  • Evaluate production efficiencies, variances, and procedures within department on a continuous basis for process improvement.
  • Ensure all production operations and equipment within department are controlled, validated, and in regulatory compliance and appropriate SOP’s and batch record documents exist and are followed and reviewed regularly.
  • Ensure batch documentation associated with the lyophilisation is of appropriate quality and delivered in a timely fashion.
  • Ensure budget targets are met while providing area of responsibility with adequate resources in facilities, equipment, and personnel to meet demand as laid out in production schedules and plans.
  • Manage the administrative aspects of the group by ensuring the preparation of performance plans, job descriptions, and conducting employee performance reviews. This includes hiring, rewarding and disciplining staff as required, providing an environment that fosters teamwork and assigning responsibility and accountability at proper levels.
  • Manage all work commitments with production personnel in area of responsibility. Provide guidance to staff in technical and management issues. Ensures proper response and methods are used on all situations that may occur in order to minimize downtime.
  • Provide technical expertise in the development of the manufacturing relationship with outside clients and facilitating the technology transfer process.
  • Support investigation into deviations and identification and implementation of corrective actions. Create an injury-free and incident-free workplace.
  • Comply with all job-related safety and other training requirements.

This position should identify all relevant and security aspects and assess corresponding risks related to his/her position and department and act in such a way that the impact is minimized; immediately report and give follow-up to any incidents (near misses, injuries, dangerous occurrences etc.), unauthorized entry or suspicious behavior to the security and department. The chosen candidate should also properly classify and store all information, and follow clear desk and screen practices at all times.

Therefore, he/she should be thoroughly familiar with and follow all safety and security rules and procedures, display positive safety and security behaviors at all times, and encourage everyone within the section to do so. Additionally, he/she should also understand how his/her position and actions and the positions and actions within the department affect the overall business safety, security, and operations, and actively participate in safety programs. He/she should assist in regular inspections of assigned area to identify any housekeeping, safety or environmental concerns. If problems are detected, immediate corrective action should be initiated and the incident should be reported. Participate in regularly scheduled training and communication sessions. Conduct departmental meetings (regularly – monthly or quarterly) to review statistics, incidents (including near misses), follow-up on assigned tasks and have a discussion on related concerns.

  • Collaborate on projects to meet customer, business and regulatory requirements.
  • Regulatory agencies – Represent company as needed during regulatory audits, etc.
  • Customers – Build rapport. Participate in customer meetings to provide technical guidance. Ensure customer requirements are met.

B.S. in a physical or biological science or production related discipline, plus 12 years relevant experience. Advanced degree preferred.

Location: North Carolina

 

 

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