Posted 2 years ago in Biotech/Pharmaceutical
Provide technical and administrative managerial leadership to the lyophilization operation activities in Steriles Production Operations.
Internal departments – 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 lyo process development / optimization.
1. Accountable for ensuring Current Good Manufacturing Practices (cGMPs) compliance of manufacturing operations to include operating procedures specifically to the operation of the freeze dryers and building utility systems.
2. Lead, plan, manage, and coordinate activities necessary to provide lyophilisation support to the Steriles operations.
3. Evaluate production efficiencies, variances, and procedures within department on a continuous basis for process improvement.
4. Ensure all production operations and equipment within department are controlled, validated, and in regulatory compliance and appropriate Standard Operating Procedures (SOP’s) and batch record documents exist and are followed and reviewed regularly.
5. Ensure batch documentation associated with the lyophilisation is of appropriate quality and delivered in a timely fashion.
6. 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.
7. 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.
EDUCATION & EXPERIENCE:
-B.S./B.A. in a physical or biological science or production related discipline, plus 7 years relevant experience.
-Relevant experience in the pharmaceutical manufacturing industry with at least 3 years in lyophilisation support role for a pharmaceutical or related industry, to include 4 years in a leadership or supervisory position.
One of the world's leading pharmaceutical manufacturing companies.
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