
Emerging Biotechnology Expert
5 days ago
This role is an exciting opportunity for a skilled professional to join a pioneering organization in the field of emerging and frontier biology. As a biotechnology expert, you will play a key part in translating bench work into commercially available products.
The organization is at the forefront of utilizing cells as a final product or deriving products from cells, often using cells as the factory to derive target products. Our first commercial breakthrough success was being certified for cultivated/cell-based meat to FSSC 22000 by a competent food regulatory body.
You will have the chance to be part of this exciting journey, owning your career and gaining firsthand exposure to new emerging modalities supporting translational sciences.
Key Responsibilities:
- Support technology transfer, manufacturing execution, and commercial readiness of cell and gene therapy products in a cGMP environment.
- Collaborate with internal/external stakeholders including QA, QC, MSAT, and commercial teams.
- Serve as Manufacturing Subject Matter Expert (SME) during audits, inspections, and due diligence.
- Involve in Process Performance Qualification (PPQ), Aseptic Process Simulations (APS), and engineering/pilot runs.
- Support in cell culture, purification, and fill-finish operations in a single-use, aseptic, cGMP facility.
Requirements:
- Minimum Bachelor's Degree in Biotechnology related disciplines, Chemical Engineering, Pharmaceutical Science or relevant discipline.
- Minimum of 2-4 years in cGMP Biologics or cell and gene therapy manufacturing with relevant industry knowledge.
- Strong knowledge of cGMP practices and global regulatory requirements.
- Able to work independently and task oriented in a dynamic environment.
- Strong team player with a strong set of interpersonal skills.
- Excellent written and verbal communication skills.
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