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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 supervise and execute floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained. You will ensure efficient use of material and equipment and assign personnel in the execution of daily operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices into manufacturing.

How you will contribute:

• Complete and manage multiple floor activities being the primary contact for troubleshooting, issue resolutions and escalations.

• In the absence of the supervisor, you will act on behalf of the supervisor while on the floor.

• Coordinate day's scheduling and staffing plan, including reallocating staff during the day for breaks, lunch, and training.

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

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

• Responsible for floor inventory and communicating schedule changes

• Monitor material consumption and coordinate all materials deliveries

• Recommend and implement process changes, safety/ergonomic improvements, and ensure work is carried out safely while notifying management of safety issues and risks.

• Conduct interviews, address minor personnel issues, escalate major issues to supervisor, ensure compliance with SOPs and safety guidelines, lead by example, and provide training.

• Initiate deviations or investigations of multiple complexities and work with cross-functional departments to identify root cause

• Implement appropriate corrective actions, assist with investigations, complete action items for GMP investigations and CAPA's and revise and author Standard Operating Procedures/Batch Records.

• Communicate any quality issues/concerns to Supervisor and QA

• Make process decisions, with the help of management and support roles, including the trouble shooting of equipment and corrective action to process deviations.

• Understand operations and contact appropriate support to ensure issues are resolved.

• Will work with equipment and supply item vendors.

What you bring to Takeda:

• Normally requires a high school diploma and 6+ years related industry experience or an Associates 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.

• Can perform manufacturing and sampling operations using aseptic technique

• Operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters

• Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.

• Prior experience or exposure in the following activities is required; standardization and measurements using bench top equipment, aseptic processing, cell culture inoculation and scale