As a Senior 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. You will also ensure good housekeeping of the facilities to keep them in good operational order in line with cGMP, safety and environmental requirements.
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.
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Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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