Senior Biotechnologist Ii

**Job Title: Senior Biotechnologist II**
**Location: Woodlands, Singapore**

**About the role**:
With mínimal 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. The individual will deliver excellence in manufacturing processing and provide support in integrate best practices, where appropriate, into manufacturing.

**How you will contribute**:
70% - Primary responsibilities include:

- Oversight and execution of all routine and critical operations as well as commissioning and validation activities
- 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
- 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
- Point of contact to troubleshoot, resolve or escalate process related issues
- 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 timeCarry out work in a safe manner, notifying management of safety issues and risks

20%
- 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

10%

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
- 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

**What you bring to Takeda**:
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
- Knowledge of cGMP’s and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department