Job Description

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)

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Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. \xe2\x80\x8b

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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 \xe2\x80\x93 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.\xe2\x80\x8b

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