Regenerative Medicine Specialist

1 week ago

Singapore beBeeQuality Full time $60,000 - $80,000
Job Overview

Our organization specializes in the development of regenerative medicine solutions using mesenchymal stem cells.

Key Responsibilities:

  • Provide technical support to ensure efficient day-to-day operations and resource management.
  • Develop quality procedures, processes, and standards aligned with company policies and local regulatory guidelines.
  • Offer assistance to production teams on quality improvements and troubleshoot issues when necessary.
  • Compile and update relevant project documentation as required.
  • Collaborate with quality managers during internal and external audits.
  • Perform quality control tests on raw materials, products, and finished goods.
  • Implement technical transfer and validation protocols for quality control assays.
  • Assist in implementing new assay methodologies and associated instrumentation.
  • Maintain proper documentation filing and perform equipment monitoring and basic housekeeping tasks.
  • Conduct routine clean room sanitization tasks to maintain ISO standards.
  • Identify and facilitate continuous process improvements.
  • Manage inventory and submit purchase requests as needed.

Requirements:

  • Biomedical science or biotechnology degree or related field.
  • 1-3 years' experience in QA/QC role or similar industry/cleanroom environment.
  • Familiarity with cGMP, FDA regulations, and ICH Guidelines for biological product manufacture.
  • Knowledge of quality assurance tools, concepts, and methodologies.
  • Experience in writing/reviewing GxP documents for good documentation and data integrity.
  • Cell/gene therapy experience preferred.
  • Expertise in cell culture, flow cytometry, and molecular biology.
  • Able to work independently and collaboratively within a team.
  • Effective communication skills across all levels.

Benefits:

The opportunity to work in a dynamic and innovative environment.

Others:

Applicants must be able to adapt to changing circumstances and priorities.

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