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Company | STEMCELL Technologies |
Address | Vancouver, British Columbia, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-31 |
Posted at | 10 months ago |
Summary
- Support the development plans for clinical antibody production and be accountable for resulting project deliverables
- Provide technical and strategic recommendations to the cross-functional project team and senior management for upstream process development activities towards cGMP antibody manufacturing for ancillary reagents
- Develop and execute upstream antibody production processes and their technology transfer to CDMOs
- Author and review process descriptions, technical reports, technology transfer documentation, SOPs, batch records, regulatory filings and other documentation as needed
- Nurture collaborations with cross-functional stakeholders to determine critical quality attributes and critical process parameters based on product’s intended use and user requirements
- Bachelors with 6+ years, Masters with 4-8 years or PhD with 0-5 years of relevant experience in upstream process development for clinical antibody/protein drug products
- Thorough understanding and hands-on experience of developing upstream protein production processes with mammalian cell lines for use in a cGMP manufacturing environment
- Experience in technology transfer to manufacturing facilities, including CDMOs
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