Scientist, Process Development, Upstream 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 Scientist, Process Development, you’ll contribute to the planning and technology transfer of upstream processes to contract development and manufacturing organizations (CDMOs) for antibody production. You will also execute CDMO activities using your technical expertise, helping to ensure successful project delivery. This is an exciting opportunity to leverage existing upstream 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 upstream process development activities towards cGMP antibody manufacturing for ancillary reagents
Support the development plans for clinical antibody production and be accountable for resulting project deliverables
Develop and execute upstream antibody production 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
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
#nonbench #phd #LI-Hybrid
STEMCELL Technologies 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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