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Job Description

Job Title: Lead Manufacturing Associate- Night Shift

Location: Lexington, MA

About the role:

As a Lead Manufacturing Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. You will oversee floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained. You will ensure efficient use of material and equipment and assigned personnel in the execution of daily operations and provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. You will report to the Supervisor, Manufacturing.

You will work 6:00pm-6:30am on a rotating 12-hour shift.

How you will contribute:

• Provide support to integrate best practices into manufacturing.

• Primary contact for troubleshooting and issue resolution or escalation

• Create and follow-up on work orders

• Communicate/ coordinate days scheduling and staffing plan

• Re-allocate staff during the day (breaks, lunch, training)

• Oversight and execution of all routine and critical operations and commissioning and changeover validation activities

• Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.)

• Responsible for floor inventory and communicating schedule changes

• Monitor material usage and coordinate all materials deliveries

• Recommend/Implement process changes/improvements or safety/ergonomic improvements.

• Ensure work is carried out in a safe manner, notifying management of safety issues

• Tiered visual management and continuous improvement

• Support tech transfer activities

• Interview candidates

• Provide feedback on staff’s performance

• Address minor personnel issues timely

• Escalate major personnel issue to the supervisor

• Ensure staff compliance with all relevant documentation and safety guidelines

• Be a role model (Lead by Example)

• Act as a resource/SME for staff

• Use safe work practices and behaviors

• Conduct training and assess effectiveness

• Help identify training needs

• Assess staff skills and provide feedback to Supervisor.

• Develop training material

• Provide training

• Initiate deviations or investigations of multiple complexities and work with departments to identify cause

• Implement appropriate corrective actions

• Complete action items for GMP investigations and CAPA’s

• Assist supervisor/engineer/facilities with investigations

• Revise and author GMP documentation 

• Communicate any quality issues/concerns to Supervisor

What you bring to Takeda:

• Normally requires a high school diploma and 6+ years related industry experience or an Associate’s Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience.

• Biotech Certificate and prior leadership experience preferred.

• Experience with systems such as SAP, LIMS and TrackWise is a plus

• Proficient in aseptic technique