Biotechnologist III

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Job Title: Biotechnologist III (12 months Contract)

Location: Singapore

About the role:

With general supervision the individual will perform routine manufacturing operations. Operates production equipment according to Standard Operating Procedures (SOPs) for the production of commercial and/or clinical products. Provide equipment 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 SOPsExecute instructions and record data in the Electronic Batch Management (EBM) systemPerform Clean-In-Place (CIP) /Steam-In-Place (SIP) activities as per MFR/SOPPerform filter integrity testing (FIT)Perform filtration and filter management as per SOPAttain good operating knowledge of the Process Control System (PCS)Attain good operating knowledge on the Manufacturing Execution System (MES)Perform equipment cleaning as per SOPPerform equipment monitoringPerform scheduled cleaning of equipmentAcquire good knowledge in handling of consumables (e.g. Bottles, filters, autoclave assemblies, etc.)Perform laboratory tasks including but not limited to sampling, pH and conductivity measurements (If required), identify and report if there's any atypical eventsPursue on-the-job training through Competency Assessments to increase knowledge and understandingRecord data into logbooks, log-sheets and forms (If applicable)Responsible for Alarm/Alert review and real time troubleshootingResponsible for logbooks and log-sheets review and follow upPerform troubleshooting and resolve process related issuesTo participate and resolve process related issues (If required)Support transfer of new processes, commission or validation of new projectCollaborate with other departments to resolve issues related to daily operationsTraining of new team members.Demonstrate good cleanroom technique in the handling of product and materialsCoordinate in-process sampling and submissionMentor and perform On-Job-Training to team membersSupport GMP and Safety audits (If required)Perform 5S housekeepingSupport 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 troubleshootingActively participate in continuous improvement initiativesPerform components staging for autoclaving and parts washerPerform assembly and disassembly of process equipmentPerform parts washer operation as per SOPsPerform loading and Operating of AutoclaveResponsible for MFR (Manufacturing Formulation Record)/SOP creation and revisionPerform monitoring for process and equipment performance during operation as per SOP/MFR, identify and report if there's any atypical eventsSupport investigation to event and deviationInterface with other departments to resolve issues related to daily operationsActively support transfer of new processes and commission/validation of new projectsActively support Change Control management 10%
The individual will manage equipment and support facility related projects bySupport 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 solutionLiaise with other department for Corrective/Preventive actions which identifiedSupport 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 RequirementsDegree in Biomedical Sciences / Chemical Engineering or related with 0 -2 years of relevant experience in the biotechnology or pharmaceutical industryDiploma 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 years of relevant experience in the biotechnology, pharmaceutical industryNitec in Biotechnology / Chemical Process Technology or related with minimum five years of relevant experience in the biotechnology, pharmaceutical industryKnowledge of plant and unit operations (autoclave, parts washers, COP and SIP systems)Demonstrate commitment to cGMP, EHS compliance aspects of clean-room and plant operationExperience in ERP/MES/control systems applications will be an added advantageAble to take initiative with good problem-solving skillsExcellent team player with hands-on attitudeAble to work on rotating shiftsAble to support overtime as requiredAble to support production demands with adjusted work scheduleAdhere to all EHS/GMP requirementAbility to wear appropriate PPE/Cleanroom gowning as per SOPAbility to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.Ability to lift, pull or push equipment requiring up to 20kgAble to climb ladders and work on platformsAble to perform confine space entrant/attendant/Supervisor/Assessor (If required)Key Skills and Competencies The individual should have moderate understanding of general job aspects and moderate understanding of the detailed aspects of the job. Possess good communication skillsPossess adequate documentation and computer skillsPossess adequate troubleshooting skills
• Familiar with current Good Manufacturing Practices (cGMP)Ability to read/understand Safety Data Sheet (SDS) and handle chemicals as per SOPAble to monitor and analyze processing parameters to identify atypical trendsAble to support Continuous Improvement ProjectsAble to perform as a subject matter expert for equipment and/or systemsMore about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Empowering our people to shine: Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations SGP - Singapore - Woodlands Worker Type Employee Worker Sub-Type Fixed Term (Fixed Term) Time Type Full time

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