Supervisor - Biomanufacturing, Central Services

Responsibilities

• Oversee biomanufacturing operations in cleanroom environments, ensuring compliance with cGMP standards and production timelines.
• Manage operation and maintenance of manufacturing equipment, including monitoring core systems and ensuring proper functionality.
• Author, review, and approve documentation such as SOPs, Batch Production Records (BPRs), and related materials.
• Ensure quality and compliance through documentation review, deviation investigations, and adherence to the Quality Management System.
• Lead audits, serve as a liaison for clients and internal stakeholders, and support regulatory readiness.
• Supervise staff, including training, mentoring, performance management, and leading team meetings or training sessions.
• Oversee facility and operational upkeep, including cleanroom housekeeping, equipment maintenance, and qualification/validation activities.
• Drive continuous improvement initiatives, training program effectiveness, and support change control and process enhancements.

Qualifications

• Bachelor’s or Associate’s degree in a scientific, engineering, or biomanufacturing field with a minimum of 2 years of relevant experience OR
• High School Diploma with a minimum of 5 years of relevant experience
• GMP experience preferred

Physical Requirements

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Occasional stooping, kneeling, crouching, bending, carrying, grasping.
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.