Development Scientist II or III (Product Development)

Canadian Blood Services•Ottawa, ON

44d•Hybrid

About The Position

Canadian Blood Services is looking for 1 Regular full-time Development Scientist II or III (based on skills and experience) 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 expertise on blood products, the processes used to manufacture them, and the analytical techniques used to characterize them. You will support development projects, primarily as part of development project teams, but also on occasion working independently. Projects include those focused 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, improving current generation products and the processes used to manufacture them, and projects introducing new testing capabilities into netCAD. In addition, you will support on-demand investigations into issues with blood products, manufacturing processes, or characterization assays. You will be actively involved in both internal and external dissemination 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.

Requirements

Completion of a PhD level degree with at least 3 years post-doctoral experience, or a master’s degree with at least 6 years’ experience, in research and development in blood, blood components or a related regulated industry.
Advanced knowledge of the processes and equipment used to manufacture blood and blood products.
Subject matter expertise in platelets, red blood cells and/or plasma blood components is required.
Advanced knowledge of experimental study design, testing, data collection, and data analysis.
Demonstrated understanding of assays and analytical approaches to interrogate the in vitro quality of blood and blood components.
Exceptionally skilled at oral and written communication, including strong ability to communicate complex technical and scientific information in plain language tailored to the audience.
Ability to design complex development studies, balancing pragmatism with achieving an appropriate level of scientific due diligence and depth of understanding.
Skilled at understanding complex processes and determining what may be critical to product quality.
Skilled at collating, analyzing, and interpreting large multivariable data sets, including ability to effectively use advanced graphical and statistical techniques.
Skilled at making presentations to internal and external groups, both virtually and in person, on a regular basis.
Skilled at effectively coaching and mentoring colleagues with less experience or expertise, supporting their continued learning.
Understanding of good manufacturing practice and good documentation practice.
An equivalent combination of education, training and experience may be considered.

Nice To Haves

Experience with buffy coat whole blood component production methods and pathogen inactivation techniques preferred.
Practical knowledge of: Cryopreservation and/or cold-storage of platelets; Freeze-/spray-drying of plasma; Whole blood for transfusion (leukoreduced or non-leukoreduced); Red blood cell quality in next-generation plastics/additive solutions; and other novel and emerging blood products is considered an asset.

Responsibilities

Provide deep scientific and technical expertise on blood products, the processes used to manufacture them, and the analytical techniques used to characterize them.
Work to deepen the organization's understanding of the biology of blood products and the impact of processes used to manufacture them.
Provide scientific expertise and rigor to ensure appropriate due diligence whenever new blood products are being introduced or changes are being made to the processes used to manufacture them.
Conduct literature reviews, synthesize available evidence, and may draw conclusions of relevance to Canadian Blood Services.
Lead the design of complex enabling and support studies as well as complex, larger scope and impact, multi-arm development studies, ensuring engagement and participation of key stakeholders.
Prepare, review and/or approve study designs, ensuring study objectives are clear and study designs are based on sound experimental principles.
Prepare, review and/or approve study protocols, ensuring alignment with the study design.
Oversee study execution as required, ensuring adherence to protocols and good lab practices.
Review, analyze and interpret data, identify and troubleshoot issues, make recommendations on and may approve any changes needed to the study.
Synthesize study results, making conclusions and recommendations based on the study data.
Work closely with external stakeholders (e.g.: vendors) and 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.
Support Medical in responding to product-related questions from hospital customers
Work independently to lead complex blood product, manufacturing process, or characterization assay issue investigations with a sense of urgency appropriate to the issue at hand, particularly where there are blood product availability implications or when suspect units have been returned from hospital customers.
Present investigation results and recommendations to key internal and external stakeholders in plain language.
Coach and mentor more junior development staff in areas of expertise and experience.
Contribute to national and international visibility of Canadian Blood Services development work by preparing and submitting abstracts to, and presenting posters and oral abstracts as applicable at, local, national and international blood industry conferences.
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.
Establish a professional network of scientific experts and collaborators from within the international blood industry.
May be invited on occasion to speak at local, national and international meetings and conferences on the development work of Canadian Blood Services or on topics reflective of their scientific and technical expertise.
May participate as scientific and technical expert on various organizational working groups and committees.
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.
May participate as a Canadian Blood Services representing member of international blood component working groups and committees (e.g. BEST, ISBT).
May hold an academic appointment at an academic institution (e.g. Adjunct Professor).