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 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