Aseptic Manufacturing Floor Lead: Drive Sterile Production

Anika; Bedford (MA); On-site; USD 95,000 - 125,000; Full time

Job summary

Anika seeks a skilled Aseptic Manufacturing Shift Lead to oversee day-to-day aseptic manufacturing on the floor, ensuring safe, compliant, and efficient execution of activities in ISO 5 and ISO 7 cleanrooms. You will provide leadership and technical guidance across assigned shifts.

The role requires deep expertise in aseptic processing, contamination control, and on-floor manufacturing execution, with strong decision-making and communication to coordinate personnel, equipment, and materials for

Qualifications

• Bachelor’s degree in engineering or related technical discipline or equivalent experience.
• 6+ years in cGMP-regulated pharmaceutical or medical device manufacturing.
• 2+ years in lead/floor leadership role with training/mentoring experience.
• Experience with aseptic processing, ISO 5/ISO 7 cleanrooms, aseptic manipulations, and syringe filling operations.

Responsibilities

• Lead daily aseptic manufacturing activities including dissolution, formulation, sterile filtration, filling, sterilization, and support cleanroom operations.
• Serve as on-floor technical lead for troubleshooting, issue resolution, escalation, and uninterrupted operations.
• Ensure product quality, batch integrity, and compliance with aseptic processing standards.

Skills

Aseptic processing

Leadership

GMP/compliance

Cleanroom operations

MRP/ERP systems

Batch records/SOPs

Education

Bachelor’s degree in Engineering/ Chemistry/ Manufacturing or related field

Tools

SAP

MRP systems

Job description

Anika seeks a skilled Aseptic Manufacturing Shift Lead to oversee day-to-day aseptic manufacturing on the floor, ensuring safe, compliant, and efficient execution of activities in ISO 5 and ISO 7 cleanrooms. You will provide leadership and technical guidance across assigned shifts.

The role requires deep expertise in aseptic processing, contamination control, and on-floor manufacturing execution, with strong decision-making and communication to coordinate personnel, equipment, and materials for