Senior Biotechnologist (Upstream)

Site Name: Singapore - Tuas

Posted Date: Aug 16 2024

Job Overview

The Senior Biotechnologist will support the set-up of the end-to-end production operations within the manufacturing facility to achieve productivity targets and objectives in a reliable, efficient, and cost-effective manner, while meeting Quality and Health, Safety, and Environment (HSE) regulations and other regulatory standards. In addition, the Senior Biotechnologist will provide process and technical support in transferring operations and technology for Hepatitis B (HBV) drug substances product manufacture from the 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

• Operations
  • 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 resources with sustained 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 documents, 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
• Planning / Scheduling
  • Adherence to project timeline
  • Assist Lead Biotechnologist / Shift Supervisor in detailed team operations planning
• 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 the agreed development plan
• Quality
  • Comply with all relevant IOQ/commissioning protocol/SOP/batch record requirements
  • Perform timely review of documentation and make necessary corrections
  • Maintain a 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 processes (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
• 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 on any items pertaining to safety, quality, and efficiency
  • Participate in the 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
• Technology Transfer
  • Participate in new technology and/or new process transfer
• Security / Safety / Environment
  • Awareness and adherence to site safety procedures
  • 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
• Interface with Other Departments / Teams
  • Coordinate with department colleagues to ensure timely supplies of materials and buffers
  • Support calibration/maintenance activities
  • Open communication on sampling requirements to QC
  • Establish good working relationships with QA, QC, and 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

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

Why GSK?
Uniting science, technology, and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.