Senior Process Development Scientist, Downstream Biologics
Job Description SummaryDo you enjoy solving complex problems, building relationships with collaborators, and continuously learning in a fast-paced and innovative environment? As a member of the Process Development, Biologics team you will work alongside experienced Engineers, Associates, and Scientists who collaborate closely on delivering robust, cost efficient, and innovative manufacturing processes for biologic products meeting appropriate regulatory and current good manufacturing practices (cGMP) requirements. As a Senior Scientist, Process Development, you’ll lead the planning and technology transfer of downstream processes for protein production. You will also interface with CDMO activities and provide your technical expertise, helping to ensure successful project delivery. This is an exciting opportunity to leverage existing downstream process development and technology transfer experience and grow as we establish new workflows for higher regulated projects at STEMCELL!
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 reagents
Create the development plans for clinical protein production and be accountable for resulting project deliverables
Provide oversight and guidance on downstream processes and their technology transfer to CDMOs
Nurture collaborations with cross-functional stakeholders to determine 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
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 for clinical antibody/protein drug products
Thorough understanding and hands-on experience of developing downstream processes for use in a cGMP manufacturing environment
Experience in technology transfer to manufacturing facilities, including CDMOs
Experience in leading and managing cross-functional projects is required
#NonBench #PhD #LI-Hybrid
STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. 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, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.
STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.
As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.
NOTE: STEMCELL’s vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process.
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