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.Responsibilities1. 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 materialsManufacturing 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 activitiesSmall equipment sourcing and material introductionCollate process information to support detailed designDesign 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+1Senior Biotechnologists:Assigned as in-charge by process / operations area to provide guidance / leadership to ensure processes are completed reliably2. Planning / SchedulingAdherence to project timelineSenior Biotechnologists: Assist Lead Biotechnologist / Shift Supervisor in detailed team operations planning3. Training & DevelopmentEnsure that he / she is trained / qualified in the current effective SOP and OJT in accordance with the assigned training curricula prior to commencing operationProactively engage N+1 to discuss personal development and follow up on agreed development planSenior Biotechnologists:To provide guidance and support to new joiner ensuring his / her smooth transition to the new environmentTo develop oneself as a process SMEGuide junior employees to ensure knowledge transfer for business continuityConduct classroom and On-The-Job (OJT) training as assigned4. QualityComply with all relevant IOQ / commissioning protocol / SOP / batch record requirementsPerform timely review of documentation and make necessary correctionsHave good quality mindset and integrity to ensure equipment and processes are rightly tested such that products can be manufactured with the highest qualityParticipate 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 requirements5. Reporting / DocumentationOperate key computer applications related to equipment used for production environmentEnsure that all documentation, i.e IOQ and commissioning protocols, are correctly recorded, cGMP complied and maintainedMaintain clear communication with N+1 and fellow colleagues, providing clear feedback of any items pertaining to safety, quality and efficiencyParticipate in development and generation of production checklists, SOPs, validation protocols and the regular review and updates of these documentsPerform VS review of the completed documentation to ensure adherence to GDPSenior 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 levels6. Technology TransferParticipate in new technology and / or new process transfer7. Security / Safety / EnvironmentAwareness and adherence to site safety procedureEnsure safe operations on the fieldIdentify 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 hazardsParticipate in Safety InspectionsParticipate in Workplace Risk Assessment8. Interface with Other Department / Team- Coordination with department colleagues to ensureTimely supplies of materials and buffersCalibration / Maintenance activities are supportedOpen communication on sampling requirements to QC- Establish good working relationship with QA, QC, TS (Calibration / Preventive Maintenance) to ensure smooth operationsKnowledge, Skills & ExperienceNITEC / HIGHER NITEC / DIPLOMA in BIOTECHNOLOGY / CHEMICAL ENGINEERING / LIFE SCIENCE or other relevant fieldExperience in Biologics / Chemical / Pharmaceutical / Food or other regulated industry preferredGood communication skillsGood documentation skillsQuality mindsetDisciplinedBasic IT skills, e.g MS Word, MS Excel & MS Powerpoint, etcBasic knowledge of cGMPFermentation BiotechnologistAseptic OperationsBasic microbiology knowledgeOperations of Fermenter and Harvest VesselOperations of CentrifugeOperations of GrinderOperations of ClarificationOperations of UltrafiltrationPurification BiotechnologistOperations of ChromatographyOperations of Sterile FiltrationOperations of Automatic Distribution SystemMaterial Prep BiotechnologistCIP of Mobile Vessel and small materialsOperations of Washing MachineOperations of sterilizing AutoclaveMedia / Buffer Prep BiotechnologistAseptic OperationsBuffer and Media Preparation with automated recipe (MPMS)To learn more about Singapore GSK and our people, please click on this link:#Li-GSKWhy GSK?Uniting science, technology and talent to get ahead of disease together.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 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\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.Important notice to Employment businesses/ AgenciesGSK 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.

GlaxoSmithKline