Biotechnology Specialist

2 weeks ago

Singapore beBeeManufacturing Full time $80,000 - $150,000
Biotechnology Specialist Job

We are seeking a Biotechnology Specialist to join our team in the field of biologics and cell and gene therapy manufacturing. This is an exciting opportunity for an individual with strong technical expertise and experience working in a cGMP environment.

The successful candidate will have a Bachelor's degree in Biotechnology or a related discipline and a minimum of 2-4 years of experience in cGMP biologics or cell and gene therapy manufacturing. They will be responsible for collaborating with internal and external stakeholders to ensure compliance, efficiency, and delivery excellence throughout the product lifecycle.

Main Responsibilities:

  • Culture and Purification Expertise: The ideal candidate will have hands-on experience in cell culture, purification, and fill-finish operations in a single-use, aseptic, cGMP facility.
  • Documentation Management: They will be responsible for authoring, reviewing, and managing cGMP documentation, including SOPs, batch records, risk assessments, and protocols.
  • Audit and Inspection Support: The specialist will serve as a subject matter expert during audits, inspections, and due diligence, ensuring seamless technology transfers and commissioning activities.
  • Data Entry and Compliance: They will ensure accurate and timely data entry in digital records, maintaining compliance with Good Documentation Practices.

Requirements:

  • Education and Experience: A Bachelor's degree in Biotechnology or a related discipline with a minimum of 2 years of experience in a cGMP/aseptic environment in biologics or cell and gene therapy.
  • Technical Expertise: Strong technical knowledge, hands-on equipment experience, and relevant industry knowledge in cGMP biologics or cell and gene therapy manufacturing.

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