Senior Manufacturing Process Scientist

Job Position: Senior Manufacturing Technician or Senior Manufacturing Process Scientist

Location: Memphis, TN

Duration: Fulltime Permanent

Relocation: Relocation Package is Provided

Our Client is looking for Senior Manufacturing Process Scientist- With protein purification etc. experience…..!!!!!

Position will be responsible for overseeing and executing the process design and manufacturing of monoclonal antibodies, polyclonal antibodies and recombinant proteins products and services sold into IVD industry. The Senior Manufacturing Process Scientist will possess ‘hands-on’ experience with various forms of chromatography (affinity, ion exchange, HIC, etc.), centrifugation, TFF/DF/UF, cell culture and fermentation. Experience with aseptic techniques particularly useful in the areas of eukaryotic cell culture, bacterial and yeast fermentation. The individual must be capable of executing and authoring Master Batch Records and Standard Operating Procedures in compliance with current Good Manufacturing Practices. This position will supervise Production Technicians.

SUMMARY & RESPONSIBILITIES: 

• Perform bio separation of recombinant proteins, monoclonal/polyclonal antibodies. Bioseparation methods to include, but not limited to, preparative centrifugation, TFF filtration, and chromatographic methods (ion exchange, size exclusion, affinity, etc.).

• Familiar with In vitro cell culture of monoclonal antibodies and fermentation of recombinant proteins.

• Develop and perform various analytical protein methods for process monitoring and characterization of in-process and final product. The methods to include but not limited to SDS-PAGE, Western Blot, ELISA, UV-VIS, and Immunoassays methods.

• Assess feasibility of contract manufacturing cell culture and purification opportunities, participate in development of proposal and costing estimates.

• Author master batch records and SOPs for transferred/developed process in compliance with all current GMP regulations and company SOPs.

• Train Production Technicians in upstream and downstream manufacturing processes.

• Develop strategies to improving yields and reducing overall manufacturing costs. Investigate alternative materials or new process equipment to improve efficiency.

• Write and execute validation protocols for new and existing manufacturing processes.

• Assist with the writing of technical reports, customer proposals, and product release specifications