Senior/Biotechnologist (1 year contract)

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)

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

#Li-GSK 

Skills
Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Manufacturing Processes, Problem Solving, Production Management, Quality Compliance, Regulatory Compliance, Risk Awareness 
 

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 APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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