Manufacturing Sciences and Technology (MS&T) Co-Op

  • Opportunity Profile:
    • Project Description: Identification and control of product-related impurities
       
      This Co-Op position will participate activities in both Upstream (protein biosynthesis) and Downstream (protein purification) of Manufacturing Sciences and Technology (MS&T) in BMS-Devens, MA to contribute to lab-scale process of producing and studying therapeutic antibodies in biopharmaceutical industry. The successful candidate will develop the capability of 1) exploring formation mechanism between product-related impurities through rational design of biochemistry studies, and 2) controlling impurities formation via upstream and downstream manufacturing processes optimization and hold time studies.
       
      This project is to understand the cause to form product-related impurities throughout the manufacturing process for a mAb-derived molecule and ultimately to develop a controlling strategy to minimize the impurity level. The Co-Op will assist to accomplish the following deliverables:
      1. Generate impure species of the molecule through tandem SEC separation and design studies to confirm the hypothesis of formation mechanism. Species will be isolated from drug substance material through prep-scale tandem SEC system, followed by analysis through HPLC-tandem SEC, SDS-PAGE and CE-SDS. The formation mechanism will be studied through 1) holding the isolated impurities at certain pH and temperature; 2) spiking the isolated species into drug substance materials to investigate any catalyst effect.
      2. Design cell culture conditions to create various levels of the impurities to study factors regulating disulfide bond reduction and free thiol group formation. Upon execution, this would validate whether certain species can be modulated during upstream process and the formation mechanism. The upstream materials will be purified through a series of chromatographic steps, and the in-process pools and drug substance will be held at different temperatures for a period of time to monitor change of impurity level as well as any correlation among species.
       
      This project is dedicated to provide an experience that will help Co-Op comprehend the purpose and function of MS&T thoroughly and efficiently by designing, executing, and interpreting the experimental results as well as by cross-functionally interacting with multiple departments.
       
      Year of Individual(s) Requested: Senior, Masters, PhD                                
       
      Major(s):Chemical/Biochemical Engineering
      Other Biochemistry related field
       
      Location of Assignment(s): Devens, MA
      Duration of Assignment(s): January 2020 to June 2020 (Co-Op)
       
      Required skills:
      • Solid knowledge of protein biochemistry and biochemical engineering principle is required.
      • Scientific understanding of protein expression and liquid chromatography is required. Lab experience with bioreactor, ÄKTA purification and/or HPLC analysis is preferred.
      • Critical thinking and innovative problem solving, proficient verbal/written communication skills, and ability to work independently as well as cooperatively.
       
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