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Senior Biotechnologist Ii
2 weeks ago
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.
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 welldefined SOPs
- Pursue onthejob 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 realtime to ensure compliance if applicable
- Attain operating knowledge of the Process Control System (PCS)
- Record data into logbooks and logsheets
- Review logbooks and logsheets 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
- 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
Quality
- Lead and participate in investigations of production events in the Global Event Management System (GEMS) or equivalent systems and work with crossfunctional 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
- Meet and maintain training requirements
- Develop and maintain personal development plan
- Provide annual performance selfassessment 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 selfmotivated team player with handson 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
- Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department
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