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Scientist, Process Development, Downstream Biologics
Company | STEMCELL Technologies |
Address | Vancouver, British Columbia, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-11-04 |
Posted at | 8 months ago |
Summary
- Develop and execute downstream 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
- Provide technical and strategic recommendations to the cross-functional project team and senior management for downstream process development activities towards cGMP antibody manufacturing for ancillary reagents
- Support the development plans and activities for cGMP antibody production and be accountable for resulting project deliverables
- Experience in technology transfer to manufacturing facilities, including CDMOs
- Bachelors with 6+ years, Masters with 4-8 years or PhD with 0-5 years of relevant experience in downstream process development for clinical antibody/protein drug products
- Thorough understanding and hands-on experience of developing downstream protein production processes with mammalian cell lines for use in a cGMP manufacturing environment
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