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Senior Scientist, Process Development (Downstream)
STEMCELL Technologies
Burnaby, CAN
Full-time
Senior · 5+ years experience
Onsite
CAD 103800-155600 yearly / year
Discovered 3 weeks ago
cGMPMSATCDMOsSOPsCAPAsISO 14001
Free
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cGMPMSATCDMOs
Key Skills for This Role
cGMPMSATCDMOsSOPsCAPAsISO 14001
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Duties and Responsibilities
- Provide technical and strategic recommendations to the cross-functional project team and senior management for downstream process development activities towards cGMP protein manufacturing for Ancillary materials
- Create the downstream development plans for protein production and be accountable for resulting project deliverables
- Provide oversight and guidance on downstream processes and their technology transfer either internally or with CDMOs
- Nurture collaborations with cross-functional stakeholders, including R&D, Quality Control, Quality Assurance & Regulatory teams, addressing critical quality attributes and critical process parameters based on product’s intended use and user requirements
- Author and review process descriptions, technical reports, technology transfer documentation, SOPs, batch records, regulatory filings and other documentation as needed
- Support manufacturing operations by using technical expertise to ensure successful manufacturing campaigns and support NCR investigations and identification of CAPAs
Knowledge and Qualifications
- Doctoral degree with at least 5 years relevant experience or Master's degree with minimum 8 years relevant experience in downstream process development &/or MSAT for antibody/protein products destined for cGMP manufacture
- Thorough understanding and hands-on experience of developing downstream processes for use in a cGMP manufacturing environment, ideally for Ancillary materials
- Experience in technology transfer to manufacturing facilities, including CDMOs
- Experience in leading and managing cross-functional projects is required
- #LI-JS1 #LI-Onsite
- STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. Scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 1,800 employees globally, most with scientific or engineering degrees, STEMCELL is proud to be the largest biotechnology employer in Canada.
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