Biotechnologist (1-year contract)

Key Responsibilities:

Operations

• Adhere to cGMP and safety requirements
• Ensure good housekeeping of associated production facilities so that they are kept in good operational order
• Identify areas for improvement and participate in continuous improvement projects to enhance operational effectiveness and efficiency
• Participate in commissioning and qualification activities as required
• Carry out other related duties as assigned by the N+1
• Assigned as in-charge by process/operations area to provide guidance/leadership to ensure processes are completed reliably

Planning

• Follow the day-to-day planning
• Assist Lead Biotechnologist or Shift Supervisor or Operations Superintendent in detailed team operations planning

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 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.

Quality

• Comply with all relevant SOP/Batch record requirements.
• Perform timely review of documentation and make necessary corrections.
• Have good quality mindset and integrity to ensure products are manufactured with the highest quality
• Participate in deviation investigation process (Process, Environmental, Maintenance/Equipment, QC) and implementation of Corrective and Preventive Action (CAPA)
• Participate in cGMP self-inspections to ensure compliance with internal SOPs and regulatory requirements

Reporting/Documentation

• Operate key computer applications related to production function
• Ensure that batch record, checklist and logbooks 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
• Participation in development and generation of production checklist, SOPs, validation protocols and the regular review and updates of these documents
• Perform VS review of completed documentation to ensure adherence to GDP
• To lead design/drafting of working instruction to ensure that it is user friendly to improve GDP

Technology Transfer

• Participate in new technology and/or new process transfer

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

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 department

• Establish good working relationship with QA, QC, maintenance, calibration to ensure smooth operations.

Basic Qualifications

• Min diploma in chemical technology, chemical engineering or biotechnology engineering
• Min 2 years of experience in Biologics, Chemical or Pharmaceutical industry
• Experience in working with GMP
• Familiar with purification/fermentation/conjugation/isolator operations/material and buffer operations

If you have the following characteristics, it would be a plus:

• A good team player and able to work independently
• Good communication and documentation skills
• Has disciplined and quality mindset
• Comfortable to work in a cleanroom environment.