Senior Biotech Manufacturing Lead – Operations & Safety

Takeda Pharmaceutical Company Limited; Lexington (MA); On-site; USD 45,000 - 70,000; Full time

Job summary

Takeda Pharmaceutical Company Limited in Lexington, MA is seeking a Lead Manufacturing Associate to drive operational excellence on the 2-2-3 rotating shift from 6:00 PM to 6:30 AM. You will lead floor operations, ensure aseptic, cGMP compliance, manage materials and schedule changes, and coach staff on safety and continuous improvement.

You will collaborate with QA, engineering, facilities, and operations to support tech transfer, deviations, CAPAs, and documentation, while striving for

Qualifications

• High school diploma with 6+ years of related industry experience or associate degree with 5+ years GMP experience.
• Experience in a manufacturing lead, team support, or coordination role preferred.
• Biotech certificate or other relevant technical certification preferred.
• Experience working with SAP, LIMS, and TrackWise preferred.
• Demonstrated proficiency in aseptic technique and cleanroom manufacturing practices.

Responsibilities

• Serve as the primary point of contact for troubleshooting, issue resolution, and escalation as needed.
• Coordinate daily scheduling, staffing, and real-time staff assignments to support operational needs.
• Oversee and execute routine and critical manufacturing operations, including commissioning and changeover/validation activities.
• Ensure documentation is completed, reviewed, and maintained in accordance with good documentation practices and cGMP requirements.
• Manage floor inventory, monitor material usage, and coordinate material deliveries and schedule changes.
• Promote safe, compliant operations by reinforcing safety practices, identifying risks, and escalating concerns appropriately.
• Support continuous improvement by applying visual management practices and recommending process, safety, and ergonomic enhancements.
• Provide team leadership through training, coaching, performance feedback, and assessment of staff skills and development needs.
• Support quality systems by initiating and contributing to deviations, investigations, CAPAs, and related GMP documentation.
• Collaborate with cross-functional teams, including QA, engineering, facilities, and operations, to resolve issues and support tech transfer activities.

Skills

Troubleshooting

Scheduling

Team leadership

cGMP knowledge

Education

High school diploma with 6+ years GMP experience

Associate degree in life sciences/engineering

Tools

SAP

LIMS

TrackWise

Job description

Takeda Pharmaceutical Company Limited in Lexington, MA is seeking a Lead Manufacturing Associate to drive operational excellence on the 2-2-3 rotating shift from 6:00 PM to 6:30 AM. You will lead floor operations, ensure aseptic, cGMP compliance, manage materials and schedule changes, and coach staff on safety and continuous improvement.

You will collaborate with QA, engineering, facilities, and operations to support tech transfer, deviations, CAPAs, and documentation, while striving for