MSAT Process Engineer - Drug Product

Senior MSAT Drug Product Specialist (Biologics)

Role Overview

This position supports MSAT (Manufacturing Science and Technology) Drug Product operations within a large-scale biologics manufacturing environment. The role is critical to ensuring robust, compliant, and scientifically sound drug product manufacturing, particularly during periods of operational recovery and site expansion. The focus is on deep technical expertise and hands-on operational support rather than project management.

Key Responsibilities

Drug Product Technical Support

• Provide MSAT Drug Product support for monoclonal antibody manufacturing
• Support high-volume commercial batch production with a strong focus on consistency and quality
• Lead deviation investigations, root cause analysis, and CAPA implementation
• Provide real-time technical oversight during batch execution and troubleshooting

Aseptic Processing & Visual Inspection

• Maintain and optimize isolator-based sterile filling operations
• Oversee visual inspection processes and drive continuous improvement initiatives
• Support sterile filtration and filter validation activities
• Ensure compliance with aseptic processing and GMP requirements

Documentation & Compliance

• Author and review batch records, SOPs, and technical documentation
• Support regulatory submissions and inspection readiness
• Collaborate closely with Quality Assurance on GMP documentation

Process Transfer & Site Support

• Support technology transfer activities to a new drug product manufacturing facility
• Provide technical expertise for process validation and qualification
• Collaborate with external manufacturing partners on process improvements and issue resolution

Required Qualifications

• Master’s degree or PhD in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline
• Minimum 5 years of experience in Drug Product manufacturing or MSAT roles
• Strong scientific depth in biologics drug product manufacturing

Mandatory Technical Expertise

• Monoclonal antibody drug product manufacturing
• Isolator operations and sterile filling
• Sterile filtration and filter validation
• Visual inspection processes
• Aseptic processing under GMP conditions

Preferred Experience

• Experience in high-volume commercial manufacturing environments
• Proven track record in deviation investigation and resolution
• Experience with technology transfer and new facility start-up
• Willingness to work close to a manufacturing site

Key Attributes

• Hands-on technical expert with strong operational focus
• Analytical problem-solver with deep scientific understanding
• Strong communicator across technical and quality functions
• Self-directed and comfortable working independently
• Quality-driven mindset with strong GMP awareness