Senior/Executive, General Operations

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 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. 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

Manage Facility:

• Ensuring that the facility is in compliance with GMP regulations. This includes developing and implementing procedures and processes, maintaining accurate and up to date records and documentation, conducting regular audits to ensure compliance, reporting incidences and preparing reports and data as required by management or to regulatory authorities.
• Assist to manage equipment- and system-related investigations, CAPAs, deviations change controls and to review records.
• Scheduling routine maintenance with service vendors for maintenance of the facility and lab & production equipment to be done on time, including preparing User Request Specification (URS), obtaining quote and following up on PO issuance.
• Ensuring proper & timely maintenance, calibration and operation of all equipment, facility M&E, safety and security equipment such as HVAC, CCTVs, access control, etc.
• Manage HVAC systems and configuration within the GMP environment.
• Managing contractors and stakeholders to ensure regulatory & safety requirements, operating standards, established protocols and the service level requirements of integrated facilities management are met.
• Partner with key stakeholders to meet user requirements and optimal functioning of all laboratory & production and building spaces.
• Responsible for managing the Building Management System, Environment Monitoring System and the facility SMS alarm including responding to environmental deviations and alarms promptly, investigating root causes, and supporting implementation of corrective actions to maintain compliance. Assist with Facilities / Engineering initiatives with cross-functional team leaders, following cGMP regulations and internal procedures in accordance with applicable regulatory standards.

Maintain workplace safety & health (WSH):

• Adhere with WSH management system and risk management plan, conducting regular safety inspections, addressing safety concerns, and coordinating with security personnel to prevent unauthorized access or other security threats.
• Evaluate WSH non-compliance, unsafe work conditions and practices to identify WSH performance gaps.
• Manage risk in the workplace, recommend, implement actions, and review effectiveness of measures to improve WSH performance and control risks.
• Conduct incident investigations and make recommendations to address root cause of incidents.
• Managing any other operational related duties/projects as assigned.

What we are looking for

1. EDUCATION, TRAINING

. Diploma equivalent Facilities Related, Engineering, Occupational Safety and Health or related fields

2. EXPERIENCE

. At least 5 years relevant working experience in managing Good Manufacturing Practice (GMP) facilities/ cleanrooms and BMS (Building Management System).

. Good knowledge of Mechanical and Electrical systems supporting GMP environment.

. Fire Safety and biosafety related knowledge / experience will have an added advantage.

. Effective stakeholder management and good communication skills.

. Good team player with positive work attitude.

. Ability to multi-task and work independently

What you need to know

Successful candidate will be offered a 3-year contract, renewable. We regret that only shortlisted candidates will be contacted. For more information about CRIS and the Business Entities, visit our websites below:

• CRIS -
• SCRI -
• NHIC -
• ACTRIS -
• PRECISE -
• STCC -
• CADENCE -