Site Name: Singapore - Tuas Posted Date: Aug 16 2024 The Senior Biotechnologist 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, Senior Biotechnologist 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 Aseptic Operations Basic microbiology knowledge Operations of Fermenter and Harvest Vessel Operations of Centrifuge Operations of Grinder Operations of Clarification Operations of Ultrafiltration To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore #Li-GSK Why GSK? Uniting science, technology and talent to get ahead of disease together. 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). 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. 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