Biotechnologist Iii

**Job Title: Biotechnologist III (Buffer Prep) - 12 Months Contract**
**Location: Woodlands, Singapore**

**Reporting to: Manufacturing Supervisor**

**About the role**:
With direct supervision the individual will perform routine manufacturing operations. Operates production equipment according to Standard Operating Procedures (SOPs), Process Control System (PCS), Electronic Batch Records (EBM), Master Formulation Record (MFR) and Checklists/Forms for the production of commercial and/or clinical products. Provide buffer preparation support for manufacturing processes in according to EHS guidelines and in a cGMP compliant manner

**How you will contribute**:
(80%) The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Electronic Batch Records (EBM), Batch Records and Forms. Primary responsibilities include:

- Perform routine and non-routine production operations as per MFR/EBM (If required)
- Perform well-defined SOPs
- Execute instructions and record data in the EBM system
- Perform Clean-In-Place (CIP) /Steam-In-Place (SIP) activities as per MFR/SOP
- Perform filter integrity testing of filters
- Perform filtration and filter management as per SOP
- Attain good operating knowledge of the Process Control System (PCS)
- Attain good operating knowledge on the Manufacturing Execution System (MES)
- Perform equipment cleaning as per SOP
- Perform equipment monitoring
- Perform scheduled cleaning of equipment
- Perform laboratory tasks including but not limited to sampling, pH, conductivity and refractometer measurements (If required), identify and report if there’s any atypical events
- Pursue on-the-job training through Competency Assessments to increase knowledge and understanding
- Record data into logbooks, log-sheets and forms (If applicable)
- Responsible for Alarm/Alert review and real time troubleshooting
- Responsible for logbooks and log-sheets review and follow up
- Perform troubleshooting and resolve process related issues
- To participate and resolve process related issues (If required)
- Demonstrate good cleanroom technique in the handling of product and materials
- Coordinate in-process sampling and submission
- Mentor and perform On-Job-Training to team members
- Perform 5S housekeeping
- Support transfer of new processes and commission/validation of new projects (If required)
- Carry out work in a safe manner, notifying management of safety issues and risks
- Involve in hands-on execution of the plant operations and assist Supervisors in troubleshooting
- Actively support continuous improvement initiatives
- Perform dispensing activities per Work Order
- Perform raw material transportation as per SOP
- Perform raw material charging as per MFR/EBM
- Perform buffer storage activities as per MFR/SOP
- Responsible for MFR (Manufacturing Formulation Record)/SOP creation and revision
- Perform monitoring for process and equipment performance during operation as per SOP/MFR, identify and report if there’s any atypical events
- Support investigation to event and deviation
- Interface with other departments to resolve issues related to daily operations
- Actively support transfer of new processes and commission/validation of new projects
- Actively support Change Control management

(10%) The individual will manage equipment and support facility related projects by:

- Support routine safety and GMP walk down and responding to findings (If required)
- Support execution of Corrective/Preventive actions which identified (If required)
- Support change control activities which assigned (If required)
- Act as a SME for investigation and solution
- Liaise with other department for Corrective/Preventive actions which identified
- Support shift change/handover activities

(10%) Staff Technical Training and Development:

- Meet and maintain training requirements
- Complete assigned training on time
- Provide technical training for area personnel
- Provide input on training material development
- Deputize for shift supervisor’s activities
- 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 Biomedical Sciences / Chemical Engineering or related with 0 -2 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 with 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry
- Nitec in B