Biotechnologist / Senior Biotechnologist

As a Biotechnologist/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**:
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.

This is a contact role, but it is convertible to a permanent role depending on your performance.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:
Must have NITEC/HIGHER NITEC/DIPLOMA in Biotechnology/Chemical Engineering/Life Science
Has relevant experience in Biologics/Chemical/Pharmaceutical/ Food or other regulated industry is preferred
Basic knowledge of cGMP
Familiar with purification and fermentation
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.

**EA Reg. No**: R2094147 EA License No : 19C9587