Senior Laboratory Officer

**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**
- Perform cell therapy Manufacturing related procedures in compliance with regulatory, GMP and safety guidelines
- Responsible for all aspects of cleanroom activities such as inventory planning, environmental monitoring and facility/equipment sanitisation with a GMP manufacturing setting.
- Ensure proper maintenance and control of manufacturing areas, clean suites and equipment.
- Responsible for accurate and timely documentation of relevant batch records, forms and log sheets for the tasks performed in compliance with GDDP (Good Data and documentation practices).
- Resolve operational issues and escalate when required
- Support non conformance investigations and change controls
- Participate in technology transfer and other cross function projects
- Assist to check equipment PM/service reports, IOQ document and etc to ensure completeness and GDDP compliance
- SLO review of documents such as, PM IOQ documents, QC test reports and log sheets
- SLO Train and mentor laboratory officers
- May act as delegate to QC Manager and may conduct departmental activities in the absence of the QC Manager

**What we are looking for**

EDUCATION, TRAINING
- Degree / Diploma in Life Sciences, Microbiology, Chemistry
- Microbiologist by training is mandatory
- Prior experience with mammalian cell culture and/or working in GMP cleanroom will be an advantage
- Prior experience as sterility assurance will be an advantage
- Attention to detail and possess analytical thinking skill
- Able to be a team player with good communication skills and strong team orientated work ethic
- Able to perform aseptic gowning and work in GMP cleanroom for long hours
- Proficient in English

EXPERIENCE
- A minimum of 3 to 5 Years of relevant working experience in Pharmaceutical Quality Systems in GMP / GDP / ATMP relevant industry.
- Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements
- Proficient in Microbiology and Quality Management Concepts.

**What you need to know