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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.
This role reports to the Shift Supervisor and will support him/her in any other tasks assigned.
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
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 (SEC/AEX)
Operations of Ultracentrifuge
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)
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Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
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