Lead GMP Aseptic Manufacturing Technician

Takeda Pharmaceutical Co.; Round Lake (IL); On-site; USD 40,000 - 63,000; Full time

Job summary

Takeda Pharmaceutical Co. in Round Lake, IL is seeking a Lead Manufacturing Technician to drive operational excellence on the manufacturing floor, ensure aseptic practices and cGMP compliance, and lead daily scheduling and staff coordination.

The role oversees routine and critical operations, coordinates material deliveries, and champions continuous improvement through visual management and cross-functional collaboration.

Qualifications

• High school diploma with 6+ years of related industry experience or an associate degree with 5+ years GMP manufacturing experience.
• Experience in a manufacturing lead, team support or coordination role preferred.
• Biotech certificate or other relevant technical certification preferred.
• Experience with SAP, LIMS, TrackWise preferred.
• Aseptic technique and cleanroom manufacturing proficiency required.
• Strong understanding of cGMP and regulatory expectations (FDA/EMA).

Responsibilities

• Serve as primary contact for troubleshooting, issue resolution, and escalation as needed.
• Coordinate daily scheduling, staffing, and real-time staff assignments.
• Oversee and execute routine and critical manufacturing operations including commissioning and changeover/validation.
• Ensure documentation compliant with good documentation practices and cGMP.
• Manage floor inventory, monitor material usage, and coordinate deliveries and schedule changes.
• Promote safe, compliant operations and escalate risks appropriately.
• Support continuous improvement through visual management and ergonomic enhancements.
• Provide team leadership through training, coaching, and performance feedback.
• Support quality systems by deviations, investigations, CAPAs, and GMP documentation.
• Collaborate with QA, engineering, facilities, and operations for tech transfer support.

Skills

Leadership in manufacturing

Team coordination

GMP knowledge

Aseptic technique

Cleanroom practices

SAP/LIMS/TrackWise

Manufacturing systems

Regulatory knowledge

Education

High school diploma + 6+ years experience

Associate degree in life sciences or engineering + 5+ years GMP

Tools

SAP

LIMS

TrackWise

Job description

Takeda Pharmaceutical Co. in Round Lake, IL is seeking a Lead Manufacturing Technician to drive operational excellence on the manufacturing floor, ensure aseptic practices and cGMP compliance, and lead daily scheduling and staff coordination.

The role oversees routine and critical operations, coordinates material deliveries, and champions continuous improvement through visual management and cross-functional collaboration.