Senior Manager of Manufacturing Science & Technology (MSAT)

Role Summary

Senior Manager of Manufacturing Science & Technology (MSAT) responsible for managing and supporting manufacturing processes throughout their lifecycle, from development to validation and throughout commercial operations. Leads a team focused on continuous improvement, embedding best practices, and enhancing manufacturing efficiency and cost-effectiveness through robust technology transfer, validation, and lifecycle management. Reports to the Director, MSAT. On-site at Smithfield, RI with initial training in Canton, MA; travel between sites required.

Responsibilities

• Work cross-functionally with manufacturing, quality, supply chain, project management, and external partners to ensure business continuity and solve complex technical problems in production
• Deliver technical expertise by evaluating current processes, identifying improvement opportunities, and implementing strategies to boost efficiency and reduce costs
• Support transfer, scale-up, and validation of manufacturing processes, ensuring regulatory compliance
• Generate quality control, manufacturing, and design control documentation; participate in preparation of CMC sections of regulatory submissions
• Partner with project teams to prepare business cases, evaluate risks, and produce validation documentation
• Cultivate talent by inspiring innovation and operational excellence while promoting continuous learning
• Manage budget and resources to meet departmental and organizational goals

Qualifications

• M.S. or higher in Biochemistry, Biotechnology, Chemical Engineering, or related field with understanding of biologics, human cell and tissue products, and/or medical devices (510k/PMA)
• 5+ years of biotechnology or pharmaceutical industrial experience in a CMC/cGMP environment
• 3+ years of management experience
• Strong analytical and problem-solving skills with a data-driven approach
• Excellent written and verbal communication, capable of aligning diverse audiences
• Proven ability to optimize resources, balance priorities, and deliver results under deadlines
• Experience in process development, scale-up, and technology transfer of cell-based therapeutics
• Experience leading complex projects and continuous improvement initiatives
• Familiar with design control principles

Skills

• Technical leadership in manufacturing science and technology
• Cross-functional collaboration
• Technology transfer, process validation, and lifecycle management
• Regulatory documentation and CMC submissions
• Project and budget management

Education

• Master‚Äôs degree or higher in Biochemistry, Biotechnology, Chemical Engineering, or related field

Additional Requirements

• On-site role with travel between Canton, MA and Smithfield, RI facilities