Senior Biotech I
2 weeks ago
- Biologics
- Plasma
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
Job ID R0124290
Date posted 05/29/2024
Location Singapore, SingaporeTakeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company's Biologics Operating Unit network, the site is Takeda's only biologics drug substance manufacturing facility in Asia. The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda's first positive energy building certified by Singapore's Building and Construction Authority's Green Mark scheme in 2022.
Job Title:
Senior Biotech I (Suite 2)
Location:
Woodlands, Singapore
About the role:
- With limited 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 engineering and validation activities.
How you will contribute:
75% Primary responsibilities include:
- Execution of routine and critical production operations
- 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.
- 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 if applicable.
- Troubleshoot and resolve process related issues.
- Initiate and document production events in the Global Event Management System (GEMS) or equivalent system.
- Informing management of events impacting production schedule
- Propose and review document revisions.
- Complete required training on time
- Carry out work in a safe manner, notifying management of safety issues and risks
- Act as a Subject Matter Expert SME for improvement projects.
- 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
10% Staff Technical Training and Development:
- Meet and maintain training requirements.
- Provide technical training for area personnel.
- Provide input on training material development.
- Develop and maintain personal development plan.
- Provide annual performance selfassessment on development plan.
Others:
- 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 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 6 years of relevant experience in the biotechnology or pharmaceutical industry.
- Nitec in Biotechnology / Chemical Process Technology or related with 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.
- Proficient at following written instructions in the form of Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable.
- Pos
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