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Biotechnologist (1-year contract)
2 weeks ago
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.
