Sr Process Engineer (MSAT) - Upstream, San Diego, CA

Sr Process Engineer (MSAT) - Upstream, San Diego, CA

Overall Responsibilities:  Manufacturing Science and Technology (MSAT) is a partner of biologics manufacturing operations and is the custodian of manufacturing processes with strong collaboration from Process Development group.  Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.  Currently seeking a Sr. Biologics Process Engineer to join the Upstream MSAT to lead and support the planning and execution of cGMP clinical phase manufacturing operations.  
Position Responsibilities: 

  • Recommend strategies for improving purification procedures for top performance using bioprocess engineering principles and protein biochemistry.  
  • Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies. 
  • Network with Process Development, Manufacturing, and Quality organizations to establish a reliable state of process control.  
  • Actively lead technical transfer and implementation of purification processes including facility fit modeling based on client needs. 
  • Actively participate in process validation activities.  
  • Build, modify, and utilize digital data storage, visualization, and analysis systems such as Minitab and/or JMP and custom web-based interfaces to enable site process monitoring and continuous process verification programs.  
  • Generate documents (technical memos, protocols, reports) related to process monitoring, product impact assessments, campaign end summary reports.   
  • Provides training as needed and ensures adherence to company policies and quality requirements. 
  • Company is in the process of building a state-of-the-art biologics manufacturing facility heavily leveraging disposable technology.  The candidate will have the opportunity to support multiple manufacturing commissioning projects. 

General Responsibilities: 

  • Operates to the highest ethical and moral standards. 
  • Complies with company's policies and procedures. 
  • Adheres to quality standards set by regulations and company policies, procedures and mission. 
  • Communicates effectively with supervisors, colleagues and staff. 
  • Ability to participate effectively as a team player in all aspects of company's business. 
  • Travels as needed between sites and to attend professional conferences and train on new technologies.  

Qualifications/Skills Required: 

  • Bachelor's degree (BS) in Chemical Engineering, Biochemistry, or equivalent with 5-10 years of relevant upstream processing experience. 
  • Working knowledge of protein purification techniques involving chromatographic and filtrationbased technologies. 
  • Well-experienced with operations of AKTA Pilot, AKTA-Ready, Flex-ACT, Starto-Flow. 
  • Detailed knowledge in creation of process methods/recipes using GE unicorn software.   
  • Strong knowledge of MS Office including Excel, PowerPoint, and Word. 
  • Must have experience within biologics CMC that includes pilot plant and/or cGMP manufacturing. 
  • Must have experience in technology transfer from development into a cGMP Manufacturing. 
  • Must be able to demonstrate significant success in technical proficiency, scientific creativity, and collaboration with others. 
  • Must be able to clearly communicate scientific information both written and oral. 
  • Ability to present technical information to both technical and non-technical audiences is required. 
  • Must be able to demonstrate sound judgment and problem-solving capabilities with exceptional interpersonal skills. 
  • Strong organizational skills are required. 
  • Project management experience is a plus. 

For immediate consideration apply today? 

Questions? Please reach out to Dustin at

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