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Manufacturing Associate

Manufacturing Associate 

Responsibilities include but are not limited to: 

• Thorough knowledge and understanding of upstream and downstream manufacturing process operations. 
• Cell splitting and amplification within shake flasks, and bioreactors. 
• Implement and initiate, CA/PA to satisfy GMP process deviations. 
• Identification of CFR compliance gaps and recommend executable remediation plan. 
• To ensure all activities meet the requirements of FDA, DEA, OSHA and EPA. 
• Writing revising, and editing SOP's for the manufacturing process and facility 
• Maintenance and organization of supply inventory. 
• Interfacing, scheduling and on-site monitoring of any outside services of all manufacturing equipment 
• Accurately document all manufacturing and/or service activities. 
• Maintaining the cleanliness and organization of all manufacturing facilities. 

Minimum Requirements: 

• BS in chemistry, biology, microbiology, or chemical engineering 
• 2-4 years of experience 
• Experience with shake flask amplification, Wave disposable bioreactors, stir tank bioreactors and initiation of deviations, investigations 
• Implementation of CA/PAs is expected of qualified candidate. 
• GMP experience is mandatory 
• Must be detail oriented, have strong written and oral communication skills. 


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