Head, Manufacturing (ACTRIS)

Head, Manufacturing (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, Manufacturing is responsible for the overall operation and administration of the GMP laboratory, including the employment of competent qualified personnel, equipment, safety, laboratory policies, quality assurance, all testing / manufacturing (including proficiency testing) and report.

 

  • Oversee all aspects of laboratory operations, including budgeting, maintenance, employment, procurement, software and documentation
  • Oversee manufacturing related procedures, change controls, deviation investigations to ensure compliance with safety, process and GMP requirements. Oversee staff career expectations and facilitate career progression
  • Oversee the development and implementation of new and/or improvement in systems, processes and procedures to increase efficiency, optimised productivity and quality in the department and ensure that other strategic objectives of the department are met
  • Oversee the safety of the department, including reviewing of department risk management plan and ensure compliance with safety regulations
  • Maintains and monitors accreditation and inspection standards, keeping the laboratory in compliance with regulatory standards by managing periodic internal, external, regulatory and accreditation audits
  • Engage and understand the needs and timelines of all stakeholders to strategically develop the department capabilities and capacity to be on course and maintain relevance
  • Ensure provision of good services through professional leadership and continually keep up to date with scientific and technological advancements
  • Maintain oversight of finances to improve cost efficiency and maintain optimal cost recovery ratio
  • Mentor team in regulatory and scientific knowledge and contribute to their skill developments, coaching and performance
  • Where required, to perform technical hand-on laboratory procedures
  • Additional duties as assigned

 

 

Job Requirements

 

  • Master of Science or Post Doctorate or relevant fields preferred.
  • At least 15 years of working experience in relevant fields preferred including at least 8 to 10 years in leadership roles.
  • Deep understanding of Cell and Gene therapy and strong knowledge in cGMP.
  • Extensive knowledge in GMP regulations, FDA guidelines, EMA standards, and other relevant and emerging regulatory frameworks.
  • 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/