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| תיאור: |
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Reports to CEO and works with QC Manager and QA Manager with primary responsibility for management of Phase I/II clinical trial cell culture manufacturing operations and establishment of a FDA licensed GMP pilot plant facility for cell culture production and related medical device products. The successful candidate will demonstrate in depth understanding of cGMP systems and biopharmaceutical APIs as well as working within time and budget guidelines.
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| דרישות: |
Develop, write and enforce written policies and procedures for all production, purchasing and inventory storage and shipping operations and maintain batch records
Hire, train, supervise and certify production staff
Plan, execute and meet production targets
IQ/OQ/PQ of all equipment and facilities, including maintenance/calibration of production equipment and clean rooms
Establish bill of materials and qualified vendor lists and manage production purchasing and inventory
Work with QC and purchasing to develop inventory specifications, acceptance and release criteria
Product inventory storage, packaging and shipping
Work with research/technology transfer to implement modifications in the manufacturing process to improve production efficiencies.
Ensure adherence to quality standards
Plan and control monthly process consumables and maintenance cost
Effective resource planning for optimizing technician and machine utilization for enhancing productivity.
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| היקף המשרה: |
מלאה |
עיר/ישוב: |
ירושלים |
תפקיד: |
מנהל |
שנות ניסיון: |
5 שנים |
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