Sr. Specialist, Engineering

Lead and Support

• Optimization, Troubleshooting, Investigations, Validation, and Process Improvement for Vaccine and Biopharmaceutical Manufacturing Processes
• Technical Support for Complex Commercial Vaccine Manufacturing
• Technology Transfer, New Process/Product Introductions, Comparability Activities, and Manufacturing Improvements

Collaborate With

• BTS-SS
• BTS-PD
• ATS
• Operations
• Engineering
• Quality Control/Assurance
• Safety
• R&D

Skills and Knowledge

• Direct Experience Supporting Complex Commercial Vaccine Processes Involving Viral/Vector-Based Production, Cell Culture, Downstream Processing, and Sterile Fill-Finish Operations
• Excellent Written and Oral Communication, Documentation, and Project Management Skills
• Strong Collaboration Skills With Experience Working Across Commercial Manufacturing Teams and Multidisciplinary Stakeholders
• Strong Analytical, Problem-Solving, and Decision-Making Skills, With a Hands-On Approach That Incorporates Safety, Quality, Compliance, Process, Equipment, Automation, Materials, and People Considerations
• Experience Supporting Complex Commercial Vaccine Manufacturing or Technical Operations Involving Viral/Vector-Based or Cell Culture-Based Antigen Production, Downstream Processing, Sterile Biopharmaceutical Operations, and Broader Familiarity With Other Vaccine or Biological Manufacturing Processes
• Experience With Process Characterization, Scale-Up/Scale-Down, Process Robustness, Technical Troubleshooting, Investigations, Protocol Execution, and Validation Support
• Understanding of Statistics and Application to Process Monitoring, Control, Investigations, and Manufacturing Data Analysis
• Experience Applying Standardized Work, Engineering Controls, Process Analytical Technology, or Protocol-Driven Studies to Improve Process Robustness and Manufacturing Performance
• Experience Introducing, Testing, or Supporting New Technologies, Process Changes, or Improvement Initiatives in Manufacturing or Technical Support Environments
• Experience Supporting Global, Multi-Site, Technology Transfer, Comparability, or Launch-Readiness Projects

Education and Experience

• Minimum Requirement: Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, Protein Chemistry, or Related Field with at least 5 Years of Experience in Vaccine and/or Biopharmaceutical Development, Process/Product Development, and/or Biological Manufacturing or Closely Related Field (Or Master of Science Degree and at Least 3 Years of Experience)