Manufacturing Shift Lead

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Job Description

With minimal supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture and Purification areas. Operates production equipment according to Standard Operating Procedures (SOPs) for the production of commercial and/or clinical products. Will support or lead engineering and validation activities. Deputy to the Shift Supervisor, acting on Supervisor’s behalf when needed. The individual will deliver excellence in manufacturing processing and provide support in integrate best practices, where appropriate, into manufacturing.

Responsibilities:

Primary responsibilities include:

• Execution of all routine and critical operations in both Upstream and Downstream or both Equipment Prep and Buffer Prep areas. Perform commissioning and validation activities in respective areas.
• Active participation in troubleshooting. Collaborate with Shift Supervisor, SME and Manufacturing Leadership for issue resolution.
• Serve as deputy for Shift Supervisor and acting Supervisor during Supervisor absences
• Monitor material consumption and coordinate all materials deliveries
• Learn and perform well-defined SOPs in all areas of responsibility
• Pursue on-the-job training through Competency Assessments to increase knowledge and understanding
• Execute instructions and record data in the Electronic Batch Management (EBM) system if applicable
• Execute instructions and record data in the Master Batch Records (MBRs) and Master Formulation Records (MFRs) if applicable
• Review manufacturing documentation and EBM or PCS alerts real-time to ensure compliance if applicable
• Attain operating knowledge of the Process Control System (PCS)
• Record data into logbooks and log-sheets
• Review logbooks and log-sheets data
• Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, EBM, batch records, etc.)
• Perform equipment monitoring
• Perform and coordinate basic laboratory tasks including but not limited to sampling, pH and conductivity measurements
• Demonstrate aseptic technique in the handling of product and materials
• Informing management of events impacting production schedule
• Propose and review document revisions
• Recommend/Implement process changes/improvements or safety/ergonomic improvements.
• Complete required training on time
• Carry out work in a safe manner, notifying management of safety issues and risks

Quality

• Lead and participate in investigations of production events in the Global Event Management System (GEMS) or equivalent systems and work with cross-functional departments to identify root causes.
• Complete action items for event investigations
• Implement appropriate CAPAs from event investigations
• Review document revisions of Standard Operating Procedures/Batch Records
• Communicate any quality issues/concerns to Supervisor and QA
• Implement Change Controls for production

Staff Technical Training and Development

• Meet and maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self-assessment on development plan

• Act as a role model (Lead by Example)
• Act as a Subject Matter Expert SME for improvement projects
• Act as a resource / SME for staff
• Provide technical training for area personnel and assess training effectiveness
• Develop training material for technical training
• Assess staff skill sets and provide feedback to Supervisor
• Perform scheduled cleaning of equipment
• Assist in the assembly and disassembly of process equipment
• Perform standardization of equipment
• Perform basic 5S housekeeping
• Initiate and follow up on Corrective Work Orders in the C3ME system or equivalent system
• Support change over activities

• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
• Any other duties as assigned by supervisor

Education and Experience Requirements

• Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses more than 4 years of relevant experience in the biotechnology or pharmaceutical industry.
• Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess more than 6 years of relevant experience in the biotechnology or pharmaceutical industry
• Nitec in Biotechnology / Chemical Process Technology or related with more than 8 years of relevant experience in the biotechnology, pharmaceutical industry.
• Excellent self-motivated team player with hands-on attitude and good communication skills
• Able to work on rotating shift
• Will work holidays and overtime as required
• May be required to adjust work schedule to meet production demands

Key Skills and Competencies

• Will be required to perform as a subject matter expert for equipment and/or systems
• Knowledge of cGMP’s and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.
• Proficient at following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable
• Self-motivated individual with the ability to complete and manage multiple floor activities in an effective and compliant manner. In the absence of the supervisor, they are the person of authority.
• Expected to act on behalf of the supervisor while on the floor
• Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
• Possess excellent communication skills to all levels throughout the organization
• Possess excellent troubleshooting skills
• Proficient documentation and proficient computer skills
• Proficient in aseptic technique where applicable
• Proficient as a system user of business systems such as C3ME and Trackwise
• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
• Ability to work in and out of 2-8 deg C Cold Rooms with appropriate personal protective equipment if required
• Ability to work in confined spaces if required
• Ability to work around chemicals (alcohols, acids & bases)

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