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Manufacturing Scientist

2 weeks ago

Singapore beBeeCell Full time
Cell Therapy Production Specialist

We are seeking a highly skilled and motivated individual to join our team as a Cell Therapy Production Specialist.

The successful candidate will be responsible for the manufacture of therapeutic cell products under current Good Manufacturing Practices (cGMP) conditions. This includes working closely with a team of technical, SME, and supervisor/manager colleagues to execute cGMP Cell Therapy production activities through to filling of final dose product within a stringent clean room environment.

The goal of this position is to develop expert technical knowledge and flawless execution of the Cell Therapy production process. Production activities occur in the classified production suite which requires change into cleanroom clothing and compliance with clean room standards.

This role could be an ideal opportunity for someone with an interest in Cell Therapy production wanting to develop their production career in a different technical/scientific area.

Thorough training and continual assessment will be provided. After training, the successful applicant would be expected to join day, weekend, and public holiday rotation shifts (12 hours).

Key Responsibilities
  • Comply with site/department EHS standards (policies, rules, and regulations)
  • Attain a thorough understanding of the principles of CGMP compliance and clean room practices
  • Contribute to appropriate maintenance of 'in-operation' production facilities and equipment, e.g., cleaning & sanitization, equipment monitoring, sampling, pH and conductivity checks
  • Prepare solutions and media followed by aseptic filtration into sterile containers
  • Revive and culture anchorage-dependent cell lines in static flasks and cell factories
  • Harvest and concentrate cell factory-generated cell cultures using tangential flow filtration and/or centrifugation
  • Finalize formulation and filling of vials, including visual inspection and cryopreservation
  • Participate in aseptic process simulations
  • Accurately and thoroughly complete batch record documentation
  • Perform environmental monitoring (viable particulates, non-viable particulates, surface, and operator)
  • Formulate media and aseptic fill media bags and bottles
Requirements

Degree/Diploma/NITEC in a related Science/Engineering discipline is required. Individuals without prior experience in biopharmaceutical manufacturing are encouraged to apply as training will be provided.

A strong team-oriented work ethic and positive attitude are essential for success in this role. Strong communication and interpersonal skills are also necessary. The ability to perform physical activities in a clean room environment, including standing, manual work (>60%), and carrying items up to 12 kg is required.