Manager, Laboratory and Production

**Job Title**:Manager, Laboratory & Production**

**Business Entity**: Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)

**Overview**

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six national R&D,

clinical translation and service programmes to advance clinical research and innovation for Singapore, and

establish important capabilities for a future-ready healthcare system.

The Business Entities under CRIS include:
Singapore Clinical Research Institute (SCRI)

National Health Innovation Centre (NHIC)

Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)

Precision Health Research, Singapore (PRECISE)

Singapore Translational Cancer Consortium (STCC)

Cardiovascular Disease National Collaborative Enterprise (CADENCE)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these

clinical research platforms and programmes are at the cutting edge of capability development and innovation.

If you are as passionate as we are in clinical trials and research, we want you

**ACTRIS**

The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the
increasing clinical demand of using cellular therapeutics to treat various life-threatening diseases. ACTRIS’
vision is to be the national and regional Centre of Excellence to facilitate 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. We
also provide value-added services such as workforce training, regulatory facilitation and ancillary material
standardization, pertaining to delivery of cellular therapy to patients.

**What you will be working on**

**(A) GENERAL**

1. Develop, plan and implement manufacturing operations and business processes for a new facility
start-up. SOPs, workflow and processes will be critically thought out to cater for cell therapy
products and must be appropriate for clinical and commercial manufacturing.

2. Assist in the preparation for all licensing and audit inspections for regulatory authorities as
necessary.

3. Oversee production of cell-based therapy products in clean rooms, which includes processing,
product storage, shipments, sampling etc

Ensure for compliance with Standard Operating Systems, Good Manufacturing Practice
(GMP) & Good Documentation Practice (GDP)

Must be knowledgeable for aseptic operations and standard cell processing procedures
such as tissue culture, cryopreservation etc.

Timely review of relevant batch record and logbooks for the tasks performed and with
adherence to GDP (Good Documentation Practice).

Ensure for compliance to GMP, environmental health and safety guidelines and any other
required industry best practices.

4. Ensure that the facility is always in proper working and clean conditions, and that there is

enough capacity to meet the production demand.

Manage equipment and clean rooms, which include timely maintenance, calibration,
monitoring and repair.

Plan for sufficient production raw materials and consumables, ahead of production processes.

Scheduling for the usage of clean suites.

Responsible for production documentation and batch records.

5. Participate in the development of new manufacturing processes, process improvement and risk
assessment activities.

Jointly lead and drive commissioning, qualification and validation activities for new facility.

Perform or supervise process validation activity for incoming new projects.

Draft, review or revise SOPS for production related documents.

Identify process gaps and opportunities for process and efficiency improvement within the lab.

Implement initiatives to streamline workflow workflows and enhance overall lab operations.

Identify potential risks, hazards or non-compliances issues and take appropriate measures to
mitigate them.

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

investigations for non-conformance.

Identify and report production problems and deviations.

Able to troubleshoot and conduct investigations.

Lead root cause analysis for complex issues and implementation of corrective or preventive
actions.

Handling compliance records such as deviation reports and change controls.

7. Supervise and mentor laboratory officers, which include providing training, guidance and

performance feedback.

8. Actively and jointly participate in the preparation and management of department’s goals,

project, budget, costing and other activities.

9. Collaborate with cross functional teams, including quality, process development and general

operations, to support efficient workflow and time release of cell therapy products.

10. Provide and communicate clear, organized and meaningful updates and analysis on

manufacturing-related operations and projects to facilitate decis