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Downstream Manufacturing LEVEL II

The main responsibilities will include but not limited to follows:
• Perform purification of proteins using various column chromatography.
• Perform column packing and qualifications of various resins.
• Operate and maintain production equipment, such as AKTA Purifier, AKTA Pilot, and AKTA Process according to the SOPs in place.
• Perform UF/DF, and various filtration methods.
• Assemble and operate Millistak Pod holders, and Millipore Cassettes holders.
• Perform Aseptic technique in Biological Safety cabinets and Laminar Air Flow.
• Perform integrity testing on various types of filters.
• Write batch records and SOPs for the downstream operations.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Purchase raw material/ production items as needed.
• Comply with safety requirements, cGMP, SOP and manufacturing documentation.
• Occasional overtime and weekend work is required.
• Interacts with other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects. 
• Participate in technology transfer of processes from Process Development to Manufacturing.  
• Work cross functional with the upstream manufacturing group to provide resources as needed.
• Perform tasks under minimal supervision, and within tight time lines to meet production schedules.
• Report any unexpected observations and suggest possible explanation and resolution.


Knowledge and Experience Required
• Bachelor’s or Master’s Degree in a life sciences (e.g. Biochemistry, Chemistry, Chemical Engineering, Biology), with 3-5 years of experience in the GMP biomanufacturing industry.  
• Experience with Downstream cGMP Manufacturing is required.  
• Experience with operating the Unicron software is required.   
• Intermediate computer skills using MS Office (Word, Excel, Power Point) preferred.
• Possess excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management and staff.
• Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task.

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