Biotechnologist III

Purpose:

• Performs functions associated with cGMP manufacturing operations for the Manufacture of clinical and bulk drug substance per safety, regulatory and operational requirements
• Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) for executing and monitoring operations
• Complete batch documentation accurately and thoroughly, while adhering to the required quality and safety standards, and in a productive, cost-effective manner.

Key Responsibilities:

Operations & Technical

• 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 Lead or Supervisor
• Assigned as in-charge by process/operations area to provide guidance/leadership to ensure processes are completed reliably

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

Technical 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 cross-functional teams

• 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.

Qualifications

• Bachelor's Degree in Science, Engineering or equivalent
• 2+ years of relevant experience working in Biologics Production facility
• Proven problem-solving skills and the ability to adapt to new requirements
• Strong working knowledge of Microsoft and other software packages, SAP, LIMS, Atlas systems preferred
• Experience with cGMP documentation and record maintenance preferred
• Excellent attitude towards work and keen willingness to learn and perform ‘hands-on’ work
• Excellent team player with strong troubleshooting and analytical skills
• Willingness and ability to perform shift work required