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Job Search Results: Jobs 1 - 1 of 1  View Titles Only  Page 1 of 1
 
Title   Company Name     Location   Date  
Director, Manufacturing 

  Scientific Search    Worldwide   14/3/2011 
Category: QA - Quality Control, Biotechnology, Engineering, Chemistry, Life Sciences, Clinical Research, Clerical/Administrative, Management/Executive, Medical Management, Pharmacy/Pharmacology, Medical Equipment, Regulatory Affairs, Healthcare, Sales/Marketing  
Education: Bachelors   Position type: Full Time Manager  Experience: 10+ years 
Area(s) of expertise desired: Bioanalytical Services, Biology, Manufacturing/Production  
Description:
Summary
This position is responsible for the technical oversight of biomanufacturing activities at contract manufacturing organizations associated with the production of critical raw materials, Drug Substance and Drug Product.
Responsibilities
• Execute on time and cost the Manufacturing Supply Forecasts through oversight of third party manufacturers based in Japan, Israel and the US : Act as Person in Plant during manufacturing campaigns
• Conduct technical audits of manufacturing operations to identify opportunities for Continuous Improvement at third party manufacturers
• Technical review of batch documents
• Trouble shoot manufacturing issues and support QA in Deviation and CAPA activities
• Support QA in the technical review of Change Requests
• Assist the Chief Technology Officer in the development of budgets
• Provide data to populate the KPI program for Manufacturing
• Other projects and assignments as required.
 
Requirements:
Requirements
• BS Degree, in either bioengineering or a biological science.
• Fifteen-plus years experience in manufacturing of biological products
• Five-plus years in the management of biopharmaceutical manufacturing operations.
• Excellent communication skills in Hebrew, both oral and written.
• Profound knowledge of GMP requirements associated in biomanufacturing in the US and Internationally.
• Knowledge of the engineering aspects of biopharmacecutical manufacturing plants
• Experience working with CMO's
• Goal oriented with a problem solving mindset
• Proficiency with computers and major software packages, e.g. Microsoft Excel, Outlook, Powerpoint, Project
• Excellent communication skills in English, both oral and written.
• Travel - 25%
 
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