Manager (Cell Specialist), Translational Sciences, ACTRIS

Consortium for Clinical Research and Innovation, Singapore (CRIS); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

CRIS is seeking a Manager (Cell Specialist), Translational Sciences to lead and coordinate activities across cell therapy programs in Singapore. You will oversee technology transfer, GMP readiness, and analytical development in collaboration with ACTRIS and SCRI to advance translational projects.

The role requires a PhD in Biomedical Sciences or related fields, deep knowledge of cell, tissue and gene therapy, and strong documentation and cross-functional communication skills in English.

Qualifications

• PhD in Biomedical Sciences or related field.
• Experience in CTGTP cell/gene therapy.
• GMP technology transfer experience.
• Proficiency in drafting documents and presentations in English.
• Ability to work in a dynamic, fast-paced environment.

Responsibilities

• Support technology transfer from clients to GMP manufacturing.
• Coordinate between clients and ACTRIS post-project acceptance.
• Evaluate equipment suitability for GMP processes.
• Understand manufacturing processes to support risk analysis.
• Draft validation plans and SOPs with input from the team.
• Lead and train junior team members.
• Oversee validation runs and data analysis for CMC documentation.
• Act as SME for assigned projects and provide technical support.
• Coordinate root cause analyses for major deviations.

Skills

PhD in Biomedical Sciences

Cell therapy

GMP

Technology transfer

Documentation in English

Education

PhD in Biomedical Sciences

Job description

Manager (Cell Specialist), Translational Sciences

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)
• Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
• 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

• Support technology transfer from clients of new cell and gene therapy processes to GMP manufacturing.
• Together with the Project Manager, be the main liaison/s between clients and ACTRIS after project acceptance and manage their expectations on scientific & technical matters relating to project progress and timelines.
• Evaluate technology and equipment suitability for GMP manufacturing.
• Understand manufacturing processes to support gap and risk analysis.
• Design and execute analytical product and process characterisation assays suitable for in process and product release.
• Draft validation plans and Standard Operating Procedures (SOPs), with support from other technical team members.
• Draft project related SOPs that will enable project progress such as aseptic process simulation; project-specific equipment etc.
• 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 process and facility fit.
• Together with the Project Manager, be the primary point of contact in alignment of project requirements and timelines with other departments till completion of engineering runs; process validation runs and aseptic process simulations.
• Be the primary point of contact for scientific & technical support for assigned projects as Subject Matter Expert.
• Coordinate root cause analysis for major process deviations during process development and manufacturing.
• 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.
• Additional duties as assigned

Job Requirements

• PhD in Biomedical Sciences or relevant fields
• Knowledge and relevant experience in the cell, tissue and gene therapy (CTGTP) field.
• Experience with performing technology transfer in a GMP environment including data analysis.
• Proficient in drafting of documents and presentations in English.
• 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/

Please note that legitimate job openings at CRIS are published through CRIS’ official careers website and authorised recruitment channels. CRIS does not request payment or sensitive personal or financial information through unauthorised channels or individuals falsely claiming to represent CRIS. Candidates are advised to verify job opportunities through CRIS’ official channels. Thank you.