Senior Biotechnologist (Upstream)

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 resources with sustained 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 documents, 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

1. Planning / Scheduling

   • Adherence to project timeline

   • Senior Biotechnologists: Assist Lead Biotechnologist / Shift Supervisor in detailed team operations planning

1. 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

   • To provide guidance and support to new joiners 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

1. 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

1. 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

1. Technology Transfer

   • Participate in new technology and / or new process transfer

1. Security / Safety / Environment

   • Awareness and adherence to site safety procedures

   • 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

1. 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 relationships 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

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