Senior Process Engineer, MSAT, Drug Substance

📋 Description

• Provide technical leadership and day-to-day process engineering support for clinical and commercial
• Serve as the process engineering SME during manufacturing operations, providing onsite support when
• Lead investigations, perform rigorous root cause analysis and develop scientifically sound CAPAs
• Assess and author technical risk assessments and change controls to support manufacturing changes
• Ensure strict compliance with cGMPs, global regulatory requirements, and internal quality systems
• Review and provide technical input into master batch records, campaign readiness plans, process

🎯 Requirements

• Bachelor's degree in chemical engineering or a related field with 8 or more years of relevant
• Experience supporting late-phase or commercial peptide or biologic drug substance manufacturing
• Comprehensive knowledge of cGMP principles, quality systems, global regulatory expectations, and
• Demonstrated experience with technology transfer, process validation, continued process
• Ability to analyze complex manufacturing data, identify subtle process trends, and translate
• Demonstrated ability to lead technical discussions with external partners and influence

🎁 Benefits

• Remote work opportunities within the United States (excluding Alaska, Arizona, Hawaii, Michigan
• Travel to corporate location in Cambridge, MA several times a year and attend company-related events
• Access to work in a setting with privacy, reliable internet, phone, and video conferencing
• Pay range: $156,000 - $176,000 USD
• Equal Opportunity Employer
• Accommodations available for candidates who require them in the selection process