Cell and Gene Therapy Product Lead

12 hours ago


Singapore beBeeManufacturing Full time $100,000 - $150,000
Lead Manufacturing Team

At our organization, we specialize in translating innovative ideas into commercially viable products at affordable prices. We utilize cutting-edge biology to develop novel products, often utilizing cells as a factory to derive our target product.

Effective leadership and strong communication skills are essential for success in this role. Critical thinking with a systematic approach is necessary for driving efficiency and delivery excellence throughout the product lifecycle.

  • Manage cross-functional teams of biotechnicians and serve as the bridge between process development and manufacturing.
  • Collaborate with stakeholders including QA, QC, MSAT, and commercial teams to drive product readiness.
  • Serve as a Subject Matter Expert (SME) during audits, inspections, and due diligence.
Requirements

A minimum Bachelor's Degree in Biotechnology or a related field is required, along with 2 years of experience in a cGMP environment in biologics or cell and gene therapy.

  • Minimum of 4-6 years of experience in cGMP Biologics or cell and gene therapy manufacturing with relevant industry knowledge and technical expertise.
  • Strong understanding of regulatory requirements such as USFDA GMP, EU GMP, HSA GMP, and PIC/S GMP.
  • In-depth knowledge of drug development processes and commercialization pathways.


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