Job Description

Site Name: Singapore - Tuas
Posted Date: Aug 16 2022

Purpose

• To participate in preparations, operations and completion of assigned process stages to ensure the production of bulk drug substances within established timing and quality standards.
• To ensure good housekeeping of the facilities so as to keep them in good operational order in line with cGMP, safety and environmental requirements.

Key Responsibilities Area

Operations

• Adhere to cGMP and safety requirements
• Ensure good housekeeping of associated production facilities so that they are kept in good operational order
• Identify areas for improvement and participate in continuous improvement projects to enhance operational effectiveness and efficiency
• Participate in commissioning and qualification activities as required
• Carry out other related duties as assigned by the N+1

Senior Biotechnologist

• Assigned as in-charge by process/operations area to provide guidance/leadership to ensure processes are completed reliably

Planning

• Follow the day-to-day planning

Senior Biotechnologist

• Assist Lead Biotechnologist or Shift Supervisor or Operations Superintendent 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 agreed development plan.

Senior Biotechnologist

• 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.

Quality

• Comply with all relevant SOP/Batch record requirements.
• Perform timely review of documentation and make necessary corrections.
• Have good quality mindset and integrity to ensure products are manufactured with the highest quality
• Participate in deviation investigation process (Process, Environmental, Maintenance/Equipment, QC) and implementation of Corrective and Preventive Action (CAPA)

• Participate in cGMP self-inspections to ensure compliance with internal SOPs and regulatory requirements

Reporting/Documentation

• Operate key computer applications related to production function
• Ensure that batch record, checklist and logbooks 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
• Participation in development and generation of production checklist, SOPs, validation protocols and the regular review and updates of these documents
• Perform VS review of completed documentation to ensure adherence to GDP

Senior Biotechnologist

• To lead design/drafting of working instruction to ensure that it is user friendly to improve GDP

Technology Transfer

• Participate in new technology and/or new process transfer

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

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 department
• Establish good working relationship with QA, QC, maintenance, calibration to ensure smooth operations.

Skill, Knowledge & Experience

Professional

• 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
• Able to work 12 hours rotating shift (including weekends).

Technical

• Basic knowledge of cGMP

Fermentation Biotechnologist

• Aseptic operations
• Basic microbiology knowledge

Purification and Coupling Biotechnologist

• Chromatography
• Ultrafiltration
• Filtration and titration (coupling)

Isolator Biotechnologist

• Aseptic operations
• Filtration

Material Prep Biotechnologist

• CIP
• Washing machine
• Autoclave

Media/Buffer Prep Biotechnologist

• Aseptic operations
• Buffer and media preparation

Business

• Good communication skills
• Good documentation skills
• Quality mindset
• Disciplined

Why GSK

Uniting science, talent, and technology to get ahead of disease together

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

• Li-GSK

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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.