Manufacturing Shift Lead – Cell Culture and Purification

About the role

Takeda is hiring a Manufacturing Shift Lead in its Woodlands site in Singapore. With minimal supervision, the role covers routine and critical manufacturing operations in Cell Culture and Purification areas, including Upstream and Downstream processes. The Shift Lead acts as deputy to the Shift Supervisor and leads engineering and validation activities.

Key responsibilities

• Perform routine and critical operations in Upstream, Downstream, Equipment Prep and Buffer Prep areas, following SOPs for commercial and clinical products.
• Support or lead engineering and validation activities; commissioning and validation in the respective areas.
• Monitor material consumption, coordinate material deliveries and perform equipment monitoring.
• Record data in the Electronic Batch Management (EBM) system, Master Batch Records (MBRs) and Master Formulation Records (MFRs) where applicable, and keep logbooks and log-sheets complete and reviewed.
• Review manufacturing documentation and EBM or PCS alerts in real time, and implement Change Controls for production.
• Take part in quality investigations in GEMS or equivalent systems, complete CAPA action items and communicate quality issues to the Supervisor and QA.
• Propose and review document revisions, recommend process, safety and ergonomic improvements, and propose document changes.
• Perform scheduled cleaning, assist in equipment assembly and disassembly, carry out basic 5S housekeeping and follow up on Corrective Work Orders in C3ME or an equivalent system.
• Provide technical training to area staff, develop training material and act as a subject matter expert for improvement projects.
• Work safely, adhere to EHS requirements and notify management of production, safety and quality events.

Required profile

• Degree in Chemical Engineering, Bioengineering, Pharmaceutical Engineering or related field with more than 4 years of experience in biotechnology or pharma; or diploma in a related field with more than 6 years; or Nitec in Biotechnology or Chemical Process Technology with more than 8 years.
• Knowledge of cGMP and applicable agency regulations (e.g., FDA, EMEA).
• Able to work rotating shifts, holidays and overtime, and to adjust the schedule to production demands.
• Ability to work in cold rooms, confined spaces and around chemicals, and to wear PPE.

Required skills

• Proficiency in aseptic technique and in following SOPs, EBM, MBRs and MFRs.
• Proficient user of business systems such as C3ME and Trackwise.
• Excellent troubleshooting, communication and documentation skills.