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BioPharm Filling Coordinator
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Pharmaceutical industry today.
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BioPharm Filling Coordinator : MedImmune
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| Job Number |
57107 |
| Employee Type |
Full Time |
| Company Name |
MedImmune |
| Location |
King of Prussia
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
12/17/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Pharmaceutical-Manufacturing |
| Relocation |
Not Required |
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MedImmune
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| Description |
Basic Qualification
•BS in relevant technical field with minimum 5 years experience in aseptic/filling operations.
•Thorough knowledge of aseptic operations, including formulation, filling, lyophilization, and dosage forms.
•Knowledgeable in cGMP, especially documentation, process, and validation.
•Excellent written and oral communications skills.
•Excellent organizational and teamwork skills.
•Strong, proven interpersonal, managerial and leadership skills.
•Experienced in scheduling, contract and project management.
Details
•Oversees secondary manufacture and testing of biopharmaceutical drug product as required supporting safety assessment studies and clinical trials for the early and late stage assets. Manages manufacture, testing, shipment, storage, and release activities across internal/external sites.
•Coordinates activities between process development, GMP Operations, and filling sites. Serves as supporting member of the BioPPD teams and has the ability to track product inventory in Comet.
•Manages and support the logistical shipping of samples for domestic and international activities.
•Works in alignment with Biopharm Process Technology and QCC scientists in oversight and implementation of appropriate technologies. Collects data, analyzes results fully and recommends follow-up actions. Support the development and creation of sampling plans in addition to logistical shipments of in process test materials. Owns and manages the creation and completion of change controls as they relate to revisions in DP specifications and site of fills.
•Using lean sigma principles support process improvements to the supply chain cycle time.
•Ensures that development and documentation are sufficient to support consistent production and regulatory filings. Prepares, reviews, and/or approves documents for use in manufacturing. May also prepare campaign summaries and documents for validation and regulatory purposes. Prepares and may approve SOP's in areas of expertise.
•Some domestic and international travel may be required. |
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| Requirements |
Preferred Qualification
•Knowledge in the packaging and labeling process is preferred.
•Working knowledge of inventory management systems, preferably Comet.
•Ability to use Lean Sigma and Root Cause Analysis methodologies for process improvement. |
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| Contact Info |
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