(senior) laboratory officer

1 week ago

Singapore MDIS Pte Ltd Full time

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.
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-functional projects.
Participate in environmental monitoring, microbiological assessment, materials and/or equipment including developing URS, SOPs and providing training related to laboratory methods and/or equipment.
Assist to check equipment PM/service reports, IOQ documents, etc. to ensure completeness and GDDP compliance.
Assist SLO review of documents such as PM IOQ documents, QC test reports and log sheets.
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 in sterility assurance will be an advantage.
Attention to detail and possess analytical thinking skills.
Able to be a team player with good communication skills and strong team-oriented work ethic.
Able to perform aseptic gowning and work in GMP cleanroom for long hours.
Proficient in English.
EXPERIENCE
A minimum of 1 to 3 years of relevant working experience in Pharmaceutical Quality Systems in GMP / GDP / ATMP relevant industry.
Fresh graduates or prior relevant internship in GTGTP may apply.
Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements.
Proficient in CTGTP QC activities and Quality Management Concepts.
What you need to know
Successful candidate will be offered a 3-year contract, renewable. Only applications viathis linkwill be reviewed. 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#J-18808-Ljbffr

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