Principal Scientist, Aseptic Control - MSAT Process

Role: Principal Scientist Aseptic Control, providing expert technical support for sterile and low bioburden manufacturing processes across cell and gene therapy, small molecule, and combination medical device programs within cGMP settings. Responsibilities: develop and oversee microbial control strategies—including gowning, facility monitoring, disinfection, filtration, and risk assessments; support investigations of contamination events; contribute to regulatory submissions and inspections; collaborate with process development and external partners to design aseptic filling operations; establish post-approval process monitoring and continuous improvement initiatives; ensure compliance with global regulatory standards and drive operational excellence. Requirements: 10+ years in aseptic drug product process development or manufacturing, with extensive knowledge of sterile processing, microbial testing, and contamination control; proven ability to lead investigations, implement risk-based strategies, and support regulatory activities; strong communication, problem-solving, and cross-functional collaboration skills. Qualifications: Degree in microbiology, engineering, or related field; 8+ years industry experience in biologics or cell therapy, ideally in a technical leadership role within cGMP facilities. High-Value: expertise in aseptic process technologies, contamination control, and facility monitoring for biologics or cell/gene therapies; experience supporting late-phase or commercial manufacturing; regulatory and inspection support. WorkSetup: Hybrid in Boston, MA; flexible onsite/work-from-home arrangement.