Head, Translational Sciences (ACTRIS)
Head, Translational Sciences (ACTRIS)
Overview
The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together seven 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)
- Singapore Medical Foundation AI Model Programme (SIMFONI)
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.
Job Description
The Head, Translational Sciences, will be responsible for leading and managing a team of scientists and laboratory officers to successfully technology transfer biologics, cell and gene therapy processes from early stage research into phase-appropriate cGMP manufacturing. The Head Translational Sciences will also provide technical and scientific expertise to evaluate, optimize and perform process development and process validation related hands-on activities along with data analysis and related documentation activities e.g. SOPs, MBRs for new projects with compliance to phase appropriate cGMP. The Head must be able to lead and work cross functionally and collaboratively with all internal and external stakeholders to deliver projects in a timely manner.
- Lead and manage a functional team of scientists and laboratory officers.
- Provide cross domain collaborator-facing leadership.
- Perform consultancy activities with early-stage product / process / assay developers to guide GMP-compliant development of the assets.
- Support technology transfer of new cell and gene therapy processes to cGMP manufacturing.
- Evaluate technology and equipment suitability for cGMP manufacture.
- Understand manufacturing processes to support gap and risk analysis.
- Establish, optimize, and develop new processes.
- Design and execute analytical product and process characterisation assays.
- Draft validation plans and Standard Operating Procedures (SOPs), with support from other technical team members.
- Oversee validation runs, that will generate manufacturing data required for CMC documentation.
- Analyse manufacturing data obtained from validation runs, incorporating various operational parameters to ensure for process and facility fit.
- Be the primary point of contact for technical support for assigned projects as Subject Matter Expert
- Coordinate root cause analysis for major process deviations during process development and manufacturing.
- Assess documentation and processes for continuous process improvement.
- 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.
- To support regulatory activities during scientific interactions with HSA, ensure inspection readiness for translational processes, foster a culture of scientific rigor, compliance and collaboration.
- Oversee change controls, deviation investigations etc to ensure compliance with safety, process and GMP requirements
- Work collaboratively with the wider ACTRIS Team to ensure effective, efficient and timely progress of projects.
Job Requirements
- PhD in the field relevant to cell and gene therapy.
- Knowledge in the Cell and Gene therapy field.
- Experience with performing technology transfer in a cGMP environment.
- Strong knowledge of and experience with mammalian cell culture experimental techniques and equipment.
- Experience in operating cell therapy manufacturing and product characterization equipment as well as data analysis.
- Experience in troubleshooting processing related issues and/or equipment.
- Excellent communication skills, outstanding action orientation, ability to work collaboratively and effectively in a cross-functional technical environment in a volatile, uncertain, complex and ambiguous field.
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/