Senior/Biotechnologist (contracted till 30 Nov 2027)

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-Orien…