Development Scientist II or III (Analytical)

About the role

Canadian Blood Services is looking for 1 Regular full-time Development Scientist II or III (based on skills and experience) with an analytical focus to join our dynamic Network Centre for Applied Development (NetCAD) team within the dynamic Innovation and Portfolio Management group of the Innovation division. Canadian Blood Services is willing to consider secondment candidates for this role.

The NetCAD team is responsible for supporting product and process development for fresh blood components and providing blood to researchers through the Blood4Research program. 

In this role, you will be a member of the netCAD blood and blood component development team, providing scientific and technical leadership on the analytical techniques used to characterize blood and blood products. Your focus will be to lead projects introducing new testing capabilities to netCAD, conduct assay development and assay characterization studies, and ensure appropriate analytical techniques are employed in netCAD studies, which focus on deepening the understanding of our products and the processes used to manufacture them, developing new or next generation products and the processes used to manufacture them, and improving current generation products and the processes used to manufacture them. You will work as part of development project teams to ensure the project’s analytical needs are met but can also expect to work independently or as part of a smaller team. In addition, you may support on-demand investigations into issues with characterization assays, blood products, or manufacturing processes. Your expertise will directly support netCAD’s development work, and you may be involved in both internal and external dissemination of analytical aspects of the development work undertaken by the team, ensuring that knowledge generated can be translated for use internally as well as adding to the international body of knowledge on blood and blood component manufacture and characterization.

Formula for success

• 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.

Desired education and skills

• 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.

What we offer you

• 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

What you can expect

• 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.