Senior Biotechnologist

Job description

Nombre del sítio: Singapore - Tuas
Fecha de publicación: Nov 28 2023

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)

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

 

 

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

  

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