As a Biotechnologist in our Value Stream, you will participate in the preparation, operation and completion of assigned process stages to ensure the production of bulk drug substances is within establish timing and quality standards. Key Responsibilities include adhering to cGMP and safety requirements, ensuring good housekeeping of associated production facilities, identifying areas for improvement, and participating in commissioning and qualification activities.
Requirements
- Adhere to cGMP and safety requirements
- Ensure good housekeeping of associated production facilities
- Identify areas for improvement and participate in continuous improvement projects
- Participate in commissioning and qualification activities
- 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
- Follow the day-to-day planning
- Assist Lead Biotechnologist or Shift Supervisor or Operations Superintendent in detailed team operations planning
- 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.
- 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
- 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
- Participate in new technology and/or new process transfer
- 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
- 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.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
