Development Scientist II or III (Analytical)

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• Provide scientific and technical expertise on analytical techniques of relevance to the characterization of blood, blood products and the processes used to manufacture them, including but not limited to:

• Understand available and emerging in vitro assays used to characterize blood and blood products, making recommendations on utility, limitations, and appropriate use.
• Design, lead and execute (independently or as part of a small team) studies to develop and characterize analytical techniques and assays to assess blood and blood products or otherwise support product and process development projects, ensuring engagement and participation of key stakeholders and in close collaboration with a cross-functional team to ensure deliverables meet the needs of netCAD and the organization.
• Provide scientific expertise and rigour to ensure appropriate due diligence for analytical techniques, including appropriate documentation of assay development and characterization.
• Work independently (i.e. to complete specific focused studies independently, including all elements from design and execution to data analysis and reporting) as well as a part of a large development project team, as determined by project needs.
• As a subject matter expert on analytical techniques, oversee aspects of study execution of larger scope and impact, multi-arm development studies as required, ensuring adherence to protocols and good lab practices.

• Review, analyze and interpret data, identify and troubleshoot issues related to analytical techniques and assays, and make recommendations, as needed.
• May review study results, ensuring conclusions and recommendations are sound based on appropriate interpretation of the study data.
• May review and approve study technical reports, ensuring the study and all findings are correctly and clearly presented in plain language.
• Conduct literature reviews, synthesize available evidence, and draw conclusions of relevance to Canadian Blood Services, particularly with respect to analytical approaches to support blood product and process development.
• Prepare, review and/or approve assay protocols, technical reports and other relevant documentation, ensuring all findings are scientifically sound, and correctly and clearly presented in plain language.
• Work with external stakeholders (e.g. assay vendors), when required, and closely with key internal stakeholders including Medical, Supply Chain, Quality, Regulatory, and Legal, providing scientific and technical expertise in support of development and validation activities, product labelling (Circular of Information), and Health Canada submissions.
• May contribute to visibility of Canadian Blood Services by preparing and submitting abstracts to, and presenting at local, national and international blood industry conferences.
• May support Canadian Blood Services contributions to the scientific literature by writing and submitting manuscripts based on Canadian Blood Services development work to peer reviewed scientific journals.
• May participate as scientific and technical expert on various organizational working groups and committees, including project steering committees, non-conformance and CAPA working groups, product design and development committee, product and services review committee.
• May participate in the organization and running of national and international scientific meetings and conferences and be asked to do peer review of scientific abstracts and journal manuscripts, on topics related to blood and blood products.

• Completion of a PhD level degree with at least 3 years' experience, or a master's degree with at least 6 year's experience, in assay development in blood, blood components or a related regulated industry.
• Knowledge of the science of blood and blood products, and the assays used to characterize them.
• Skilled at understanding complex processes and determining what may be critical to product quality.
• Proven ability to design and lead studies establishing and characterizing assays and analytical approaches, balancing pragmatism with achieving an appropriate level of scientific due diligence and depth of understanding.
• Hands-on experience of analytical methods including:

• Flow cytometry;
• ELISA & other colourimetric/fluorometric plate-based assays;
• Enzymatic assays (e.g.: ATP or 2,3-DPG measurement in RBC);
• Coagulation and aggregation assays (e.g.: platelet aggregometry, viscoelastic testing, coagulation factor panels);
• Cell morphology, ektacytometry and deformability assays (e.g.: microscopy, LORRCA, microfluidics systems);
• Protein assays (e.g.: SDS-PAGE, immunoprecipitation, etc.).
• Advanced knowledge of data collection and data analysis.
• Experience with preparing work instructions/standard operating procedures.
• Understanding of good manufacturing practice and good documentation practice.
• Skilled at oral and written communication, including ability to communicate complex technical and scientific information in plain language and with appropriate data visualization, tailored to the audience.
• Skilled at collating, analyzing, and interpreting large data sets, including ability to effectively use advanced graphical and statistical techniques.
• Skilled at effectively coaching and mentoring colleagues with less experience or expertise, supporting their continued learning.
• An equivalent combination of education, training and experience may be considered.

• 4 weeks' vacation
• Annual performance award up to 10%
• Comprehensive group health, dental and vision benefits for you and your family
• Defined benefit pension plan
• Employee discounts, wellness program, professional resources

• This role will work predominantly onsite at the Canadian Blood Services development location in Vancouver, BC, with remote work possible on days when the role does not require in-person presence.
• You will work Monday to Friday, 37.5 hours per week, 7.5 hours per day.
• You may be expected to travel quarterly for this role, and as required.

Canadian Blood Services