Biotechnology Specialist

This is an exciting opportunity to join a rapidly transforming industry, applying technology and data in new ways. As part of the Global Manufacturing and Supply team at Takeda, you will be working on four platforms: Small Molecules, Biologics, Plasma, and Cell and Gene.

Your work will matter every day as you use your skills to help manufacture therapies for patients. You will have the opportunity to pursue unique experiences and build new skills, knowing that the work you do makes an impact – on our patients, our people, our planet, and on yourself.

With general 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.

Key responsibilities include:

• Execution of routine and critical production operations
• Learn and perform well-defined SOPs
• 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
• Attain operating knowledge of the Process Control System (PCS)
• Record data into logbooks and log-sheets
• Review logbooks and log-sheets data
• Perform equipment monitoring
• Perform basic laboratory tasks including but not limited to sampling, pH and conductivity measurements
• Demonstrate aseptic technique in the handling of product and materials if applicable
• Troubleshoot and resolve process related issues
• Initiate and document production events in the Global Event Management System (GEMS) or equivalent system
• Propose document revisions
• Complete required training on time
• Carry out work in a safe manner, notifying management of safety issues and risks

The individual will manage equipment and support facility related projects by:

• Perform scheduled cleaning of equipment
• Assist in the assembly and disassembly of process equipment
• Perform standardization of equipment
• Perform basic 5S housekeeping
• Initiate Corrective Work Orders in the C3ME system or equivalent system
• Support change over activities

The role also involves staff technical training and development, meeting and maintaining training requirements, developing and maintaining personal development plans, providing annual performance self-assessment on development plan, and adhering to any applicable EHS requirements.

Required education includes a degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related with 0 - 2 years of relevant experience in the biotechnology or pharmaceutical industry.

Alternatively, a 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 with 4 years of relevant experience in the biotechnology or pharmaceutical industry.

Or Nitec in Biotechnology / Chemical Process Technology or related with 6 years of relevant experience in the biotechnology, pharmaceutical industry.

Full awareness of current Good Manufacturing Practices (cGMP), proficient documentation, and proficient computer skills are essential. Additionally, good communication skills, troubleshooting skills, and ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas are necessary.