Laboratory Officer

**Job Title**

Laboratory Officer (3-year Contract)

**About ACTRIS**

The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established on

20 April 2020 to meet the increasing clinical demand of using cellular therapeutics to treat

various life-threatening diseases. ACTRIS’s vision is to be the national and regional Centre of

Excellence for discovery, process development and manufacturing of cellular-based

therapeutics across the broad spectrum of immunotherapy and regenerative medicine,

encompassing both investigational and approval products for the local market. ACTRIS aims

to achieve accreditation from national and international regulators to ensure quality compliance

of resource-efficient cellular therapy manufacturing. Our common goal is to promote and foster

the entire value of chain of cellular therapy ecosystem through enabling translational research

and development, manufacturing, clinical service provision, and commercialisation by serving

the healthcare, academic and industrial sectors. ACTRIS will also provide value-added

services such as workforce training, regulatory facilitation and ancillary material

standardization, pertaining to delivery of cellular therapy to patients.

Production support of cGMP batches in the manufacturing facility; including waste disposal,

product storage, shipments, sampling etc
- Demonstrated understanding and compliance in Standard Operating Systems,

Current Good Manufacturing Processes (CGMP) & Good Documentation (GDP).
- Executes processes in production while strictly adhering to cGMP, environmental

health and safety guidelines and any other related regulations which could apply
- For aseptic operations strictly follow aseptic techniques and practices practice as

per relevant SOPs.
- Perform routine QC sampling and in-process testing of the product at various

stages throughout manufacturing (e.g. bioburden sampling, water sampling).
- Timely completion of relevant batch record and logbooks for the tasks performed

and with adherence to GDP (Good Documentation Practice).

Perform routine and repetitious work within defined parameters.
Ensure safety, security, and the environment in all aspect of the daily activities and any

potential safety hazardous are addressed and corrected immediately.
- Follow safety and quality compliance at all times and communicate in a timely

manner to the superior if any anomalies are observed.

Perform simple calibration and maintenance of all equipment in manufacturing facilities to
ensure proper working conditions

Perform regular environmental monitoring and sanitization of facilities to maintain facilities
standard

Participate in the development of new manufacturing and quality control processes.
- Identify processing gaps and assist with implementation of new technologies.

Restricted, Non-Sensitive
- Revise complex procedures or initiate new procedures as applicable.
- Participate in departmental projects and quality working teams.
- Support process validation activities under the supervision of Manufacturing

Lead (IQ, OQ, PQ, PV)

Support out-of-specifications manufacturing investigations, change control and root cause

investigations for non-conformance.
- Troubleshooting of acute production problems.
- Draft complex Document Change Requests and complete major Non
- Conformance Investigations.
- Leading root cause analysis when complex abnormities are detected and

implementation of the correct preventive actions.

In charge and responsible for assigned workstation or area of manufacturing.
- Carry out the cleaning and upkeep of the production equipment and classified

areas in manufacturing area as per relevant SOPs and the Batch Record.
- Perform stock check of consumables and inform Manager/Lead technician for

required materials.
- If required, perform Microbial sampling and swabbing of room and equipment.

Responsible for production documentation of the equipment and batch records.
- Handling compliance records such as deviation reports and change controls.

Ensuring the equipment is validated and well maintained and ensuring there is enough

capacity to meet the production demand.

May act as delegate to the Lead and/or Supervisor and may conduct departmental activities

in their absence.

Any other duties as and when assigned by the Manager.

**Requirements**:
Minimum Diploma in Engineering (Chemical/Biomedical), Biotechnology, Life Sciences or

equivalent.

3 to 5 years of relevant experiences in biopharmaceutical and/or medical device

manufacturing industry and prior technical knowledge in batch biopharmaceutical

processing will be an advantage

Clean room with sterile or aseptic processing knowledge and experience.

Good understanding of safe working practices and cGMP.

Highly motivated to work in pharmaceutical Industry.

Able to work as a team.

Able to work rotating shift if required.

Highly motivated, proactive, and enthusiastic team player with demonstrated history o