Senior/Biotechnologist (contracted till 30 Nov 2027)

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About the role

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 al

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