Senior Manager of Manufacturing Science & Technology (MSAT)

Role Summary

The Senior Manager, Manufacturing Science & Technology (MSAT) leads and supports manufacturing processes across their lifecycle, from development to validation and commercial operations. The role drives continuous improvement, embeds best practices, and enhances manufacturing efficiency and cost-effectiveness through technology transfer, validation, and lifecycle management. It involves direct supervision of scientific staff and close collaboration with stakeholders inside and outside the company. The position applies scientific and engineering principles to design, optimize, and scale manufacturing processes, ensure seamless technology transfer, and resolve challenges across the product lifecycle. This is an on-site role primarily at the Smithfield, Rhode Island facility, with initial training at the Canton, MA facility and 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 that may arise in production
• Deliver technical expertise by evaluating current processes, identifying improvement opportunities, and implementing innovative strategies to boost efficiency and reduce costs
• Support the transfer, scale-up, and validation of manufacturing processes, ensuring compliance with regulatory standards
• Generate quality control, manufacturing, and design control documentation; participate in the 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 nurturing a culture of continuous learning and growth
• Manage budget and resources effectively to meet departmental and organizational goals

Qualifications

• M.S. or higher in Biochemistry, Biotechnology, Chemical Engineering, or related field with strong 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 required
• 3+ years of management experience required
• Strong analytical and problem-solving skills, with a data-driven approach to decision making
• Highly skilled communicator, both written and verbal, adept at crafting clear messages and driving alignment with audiences at every level of the organization
• Proven ability to optimize resources, balance competing business priorities, and consistently deliver results under tight deadlines
• Strong track record in process development, scale up, and technology transfer of cell-based therapeutics
• Expertise in leading complex projects and spearheading continuous improvement initiatives
• Familiar with the principles of design control

Skills

• Analytical thinking and data-driven decision making
• Leadership and people management
• Technical communication and cross-functional collaboration
• Process development, scale-up, and technology transfer
• Regulatory understanding of CMC and design control

Education

• M.S. or higher in Biochemistry, Biotechnology, Chemical Engineering, or related field

Additional Requirements

• On-site work at Smithfield, RI facility with travel to Canton, MA as needed