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  • Senior Biotechnologist Singapore
  • GSK in Singapore, , Singapore
  • jobs
  • 5 days ago

jobs description

Nombre del sítio: Singapore - Tuas
Fecha de publicación: Nov 28 2023

The Biotechnologist / Senior Biotechnologist 1, 2 & 3 will support the set-up of the end-to-end production operations within the manufacturing facility so as to achieve productivity targets and objectives in a reliable, efficient and cost-effective manner, and meeting Quality and Health, Safety and Environment (HSE) regulations and other regulatory standards. In addition, Biotechnologist / Senior Biotechnologist 1, 2 & 3 will also provide process and technical support in transferring operations and technology for Hepatitis B (HBV) drug substances product manufacture from current production site in Belgium RX59 to Singapore (SG) Tuas.

This role reports to the Shift Supervisor and will support him/her in any other tasks assigned.

Responsibilities

1. Operations

- Responsible to support the set-up of the end-to-end production operations within the future manufacturing facility. Manufacturing activities include:
•... Preparation and Supply of media, buffers and materials
• Manufacturing of intermediates and drug substance

- Optimize the utilization of capacity and manufacturing resource with sustain efficiency in:
• Manpower (For Senior Biotechnologist)
• Process

- Adhere to cGMP and safety requirements

- Meet project milestones and deliverables, e.g:
• Participate & Execute Commissioning and Qualification activities
• Small equipment sourcing and material introduction
• Collate process information to support detailed design
• Design and draft relevant document, e.g SOP, Checklist, OJT and WRA

- Identify areas for improvement and participate in continuous improvement projects to enhance operational effectiveness and efficiency

- Carry out other related duties as assigned by N+1

Senior Biotechnologists:
• Assigned as in-charge by process / operations area to provide guidance / leadership to ensure processes are completed reliably

2. Planning / Scheduling
• Adherence to project timeline
• Senior Biotechnologists: Assist Lead Biotechnologist / Shift Supervisor in detailed team operations planning

3. Training & Development
• Ensure that he / she is trained / qualified in the current effective SOP and OJT in accordance with the assigned training curricula prior to commencing operation
• Proactively engage N+1 to discuss personal development and follow up on agreed development plan

Senior Biotechnologists:
• To provide guidance and support to new joiner ensuring his / her smooth transition to the new environment
• To develop oneself as a process SME
• Guide junior employees to ensure knowledge transfer for business continuity
• Conduct classroom and On-The-Job (OJT) training as assigned

4. Quality
• Comply with all relevant IOQ / commissioning protocol / SOP / batch record requirements
• Perform timely review of documentation and make necessary corrections
• Have good quality mindset and integrity to ensure equipment and processes are rightly tested such that products can be manufactured with the highest quality
• Participate in deviation investigation process (Process, Environmental, Maintenance / Equipment, QC) and implementation of Corrective and Preventive Actions (CAPA)
• Participate in cGMP self-inspections to ensure compliance with internal SOPs and regulatory requirements

5. Reporting / Documentation
• Operate key computer applications related to equipment used for production environment
• Ensure that all documentation, i.e IOQ and commissioning protocols, are correctly recorded, cGMP complied and maintained
• Maintain clear communication with N+1 and fellow colleagues, providing clear feedback of any items pertaining to safety, quality and efficiency
• Participate in development and generation of production checklists, SOPs, validation protocols and the regular review and updates of these documents
• Perform VS review of the completed documentation to ensure adherence to GDP

Senior Biotechnologists:
• To lead design / drafting of working instruction & SOP to ensure that it is user friendly to improve GDP and also instructions within is clear and understandable for all levels

6. Technology Transfer
• Participate in new technology and / or new process transfer

7. Security / Safety / Environment
• Awareness and adherence to site safety procedure
• Ensure safe operations on the field
• Identify and report all potential safety issues (personal protection requirement, equipment protection, way of working, etc)
• Ensure proper housekeeping of assigned production areas to minimize safety hazards
• Participate in Safety Inspections
• Participate in Workplace Risk Assessment

8. Interface with Other Department / Team

- Coordination with department colleagues to ensure
• Timely supplies of materials and buffers
• Calibration / Maintenance activities are supported
• Open communication on sampling requirements to QC

- Establish good working relationship with QA, QC, TS (Calibration / Preventive Maintenance) to ensure smooth operations

Knowledge, Skills & Experience
• NITEC / HIGHER NITEC / DIPLOMA in BIOTECHNOLOGY / CHEMICAL ENGINEERING / LIFE SCIENCE or other relevant field
• Experience in Biologics / Chemical / Pharmaceutical / Food or other regulated industry preferred
• Good communication skills
• Good documentation skills
• Quality mindset
• Disciplined
• Basic IT skills, e.g MS Word, MS Excel & MS Powerpoint, etc
• Basic knowledge of cGMP

Fermentation Biotechnologist
• Aseptic Operations
• Basic microbiology knowledge
• Operations of Fermenter and Harvest Vessel
• Operations of Centrifuge
• Operations of Grinder
• Operations of Clarification
• Operations of Ultrafiltration

Purification Biotechnologist
• Operations of Chromatography
• Operations of Sterile Filtration
• Operations of Automatic Distribution System

Material Prep Biotechnologist
• CIP of Mobile Vessel and small materials
• Operations of Washing Machine
• Operations of sterilizing Autoclave

Media / Buffer Prep Biotechnologist
• Aseptic Operations
• Buffer and Media Preparation with automated recipe (MPMS)

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

#Li-GSK

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