Cell / Assay Specialist / Manager, Translational Services, 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 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
Senior Manager / Manager
(1) Support technology transfer from collaborators of new cell and gene therapy processes to GMP manufacturing.
(2) Be the main liaison between collaborator and ACTRIS after project acceptance and manage their expectations on matters of project progress and timelines.
(3) Evaluate technology and equipment suitability for GMP manufacturing.
(4) Understand manufacturing processes to support gap and risk analysis.
(5) Design and execute analytical product and process characterisation assays suitable for Product release.
(6) Draft validation plans and Standard Operating Procedures (SOPs), with support from other technical team members.
(7) Draft of any project related SOPs that will enable project progress.
(8) Oversee validation runs, that will generate manufacturing data required for CMC documentation.
(9) Analyse manufacturing data obtained from validation runs, incorporating various operational parameters to ensure for process and facility fit.
(10) Be the primary point of contact in alignment of project requirements and timelines with other departments.
(11) Be the primary point of contact for technical support for assigned projects as Subject Matter Expert
(12) Coordinate root cause analysis for major process deviations during process development and manufacturing.
(13) Any other scope assigned by Reporting Officer.
Specific for Senior Manager
(14) Develop side-line manufacturing and analytical method capabilities to strengthen ACTRIS’s inhouse capabilities.
(15) Show case manufacturing accomplishments to external parties in the form of conferences, talks or seminars to bolster ACTRIS’s reputation.
(16) Perform data analytics on past runs to derive trending for continuous process improvement.
(17) Lead and train other technical team members to enable effective knowledge sharing and expansion, and to provide support in delivery of projects that are assigned to junior team members.
What we are looking for
(1) Master of Science or PhD in Biomedical Sciences or relevant fields preferred.
(2) Knowledge and relevant experience in the cell, tissue and gene therapy (CTGTP) field.
(3) Experience with performing technology transfer in a GMP environment including data analysis.
(4) Proficient in drafting of documents and presentations in English.
(5) Able to work in a dynamic and fast-paced environment.
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 – https://www.cris.sg
- SCRI – https://www.scri.edu.sg
- NHIC – https://www.nhic.sg
- ACTRIS – https://www.actris.sg
- PRECISE – https://www.npm.sg
- STCC – https://www.stcc.sg
- CADENCE – https://www.cris.sg/our-programmes/cadence/