Senior Manufacturing Process Scientist

Job Description

They must have protein purification experience including non-labeled proteins and They are NOT looking for candidates with molecular/PCR/gene cloning, etc.

Summary Description: 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. Duties: o 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.). o Familiar with In vitro cell culture of monoclonal antibodies and fermentation of recombinant proteins. o 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. o Assess feasibility of contract manufacturing cell culture and purification opportunities, participate in development of proposal and costing estimates. o Author master batch records and SOPs for transferred/developed process in compliance with all current GMP regulations and company SOPs. o Train Production Technicians in upstream and downstream manufacturing processes. o Develop strategies to improving yields and reducing overall manufacturing costs. Investigate alternative materials or new process equipment to improve efficiency. o Write and execute validation protocols for new and existing manufacturing processes. o Assist with the writing of technical reports, customer proposals, and product release specifications

Qualifications

Required Qualifications: o Ph.D. with 3+ years of industrial experience or MS with 6+ years of industrial experience in a GMP or GLP environment. o Extensive knowledge and hands on experience of protein purification and characterization. o Experience with virus like proteins and viruses a plus. A knowledge of AKTA Unicorn software and disposable systems a plus. o Hands on experience with in vitro cell culture and recombinant protein fermentation o Ability to independently apply bioseparation basic theory and scientific principles to conduct downstream process development for proteins. o Proven experience with process scale-up procedures. o Extensive knowledge and hands on experience with protein analytical methods including (SDS-PAGE, Western Blot, ELISA, BCA, UV-VIS, HPLC methods etc). o Concise and accurate oral and written reporting of technical including batch records, SOPs, validation protocols and customer proposals. Requirements (Physical, Mental, Environmental Demands): o Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility. o Must be able to concentrate, analyze and solve complex issues throughout the course of the work day. o Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day. o Ability to sit for long periods of time, stoop, reach, bend throughout the course of the work day. o Must be able to lift up to 30lbs. multiple times daily. o Must be able to travel by air/car to other locations of MBI as needed. o May be required to work outside normal business hours including evenings and/or weekends to support business needs.

Additional Information

Manisha Jathar

732 429 1850