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Manager, Cell Bank Manufacturing & Testing
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Manager, Cell Bank Manufacturing & Testing : GlaxoSmithKline
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| Job Number |
60820 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
King of Prussia
Pennsylvania
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| Salary (year) |
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| Experience |
6 to 9 Years |
| Start Date |
6/24/2010 |
| Industry |
Pharmaceutical |
| Job Type |
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| Required Degree |
PhD |
| Relocation |
Not Required |
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| Description |
Basic Qualification
PhD with minimum eight years relevant experience. Must have direct supervisory experience. Thorough knowledge of cell banking operations, including media preparation, cell bank manufacturing, and testing. Knowledgeable in cGMP and relevant regulatory requirements.
Details
• Manages Cell Banking programs within Biopharm GMP Operations including at contract manufacturing and testing operations. Responsible for ensuring timely and successful manufacture and testing of cell banks as required to support Biopharm GMP Operations. Oversees manufacture, testing, shipment, storage, and release activities, including inventory management.
• Responsible for ensuring timely and successful project management of both mammalian and microbial GMP cell bank manufacturing, testing and release, and technical transfer of cell bank manufacturing process within project management team matrix, to ensure project schedule and time lines are met.
• Coordinates activities between cell line development, project teams, and GMP Operations. Represents the department at and potentially leads BioPPD, Technology Transfer, and other multi-disciplinary teams.
• Ensures that records, reports and other GMP documents are sufficient to support consistent production, testing and regulatory filings. Prepares and approves documents for use in manufacturing, testing, release, and regulatory filings.
• Establishes contractual agreements with external manufacturing operations and testing labs. Coordinates the testing of cell banks with QC and external testing labs. Provides budget input regarding cell bank manufacturing and testing to department and project teams.
• Serves as cell banking subject matter expert for regulatory questions and inspections.
• Facilitates the transfer of cell banks to manufacturing groups and testing labs, including coordinating shipment of cultures to facilities worldwide.
• Some domestic and international travel required. |
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| Requirements |
Preferred Qualification
• Background in cell line development / cell banking, microbiology, virology and/or molecular biology.
• Excellent organizational and teamwork skills.
• Strong, proven interpersonal, managerial and leadership skills.
• Demonstrated project management experience working with cross-department team members and efficiently coordinating activities with both internal and external customers
• Excellent written and verbal communication skills
• Excellent troubleshooting/problem analysis skills, including Lean Sigma and Root Cause Analysis methodologies. |
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