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.

Key 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 (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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Skills

Why GSK?

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.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact [email protected]. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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