Senior Scientist, Assay Development

Technical Operations – Assay Development         ·        Toronto, Ontario (Onsite)        ·       Full time

Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

Responsibilities

• Design and execute in vitro experiments to assess, develop and optimize novel multiparameter flow cytometry assays to characterize cell therapy manufacturing and formulation processes
• Ensure that flow cytometry assays meet requirements for the intended use of the assays, which includes characterization, lot release, stability and comparability testing of development and manufacturing batches and establish phase-appropriate specifications
• Plan and execute analytical method transfers with upstream and downstream analytical teams; qualify assays as appropriate and provide training and further qualification/validation support as needed
• Co-ordinate and interact with other functions to ensure a thorough understanding of the requirements for phase-appropriate flow cytometry assay development
• Analyze experimental data to draw conclusions that support decision making and next steps within and across projects
• Prepare and present project plans and regular project progress updates and recommendations
• Prepare, review, and approve experimental protocols, reports, standard operating procedures and other scientific and quality documents
• Requires hands-on laboratory work in addition to supervision of junior scientists and research associates
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations as required
• Contribute to preparation of CMC sections of regulatory applications
• Collaborate with internal and external stakeholders to identify and evaluate new technologies and incorporate them into product quality assessments as appropriate
• Communicate regular updates on the latest scientific, regulatory or quality trends in cytometry
• Serve as a scientific and technical expert in flow cytometry to support other assay development activities, and provide mentorship and guidance to junior team members
• Contribute to building a culture that embraces scientific excellence, integrity, urgency, courage and community

Requirements

• Advanced (PhD or MSc) degree in biological sciences, or similar with 5+ (PhD) or 13+ (MSc) years of relevant flow cytometry experience in a contract research organization, biotechnology or pharmaceutical company, or similar industry environment
• Significant hands-on experience in developing, optimizing and qualifying multiparameter flow cytometry assays according to industry and best practices standards is required
• Demonstrated expertise in multiparameter flow cytometry procedures, equipment and software (e.g. FlowJo) including experience with operation, maintenance and daily calibration of cytometers
• Hands-on experience in mammalian cell culture is required
• Experience with other flow data analysis and visualization programs (eg. CytExpert, Cytobank, FCS Express, Omix) is a plus
• Experience in statistical analysis of data is desired
• Experience with GxP guidelines/documentation and general GxP experience in analytical development is an asset but not required
• Proven ability to structure, plan, and execute on complex projects and programs in a fast-paced environment
• Commitment to high-quality research and documentation standards, data integrity and flow cytometry best practices
• Excellent organizational and problem-solving skills, with demonstrated ability to extend these across a team and respond as needed to changing functional priorities
• Experience in supervising and guiding employees, and working collaboratively in a cross-functional environment is preferred
• Excellent interpersonal, verbal and written communication skills

Other Relevant Information:

• Candidate will be working in office and controlled laboratory environments
• Risk of potential exposure to chemicals and biohazards consistent with somatic cell therapy culture

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BlueRock Therapeutics Company Culture Highlights

• Winner of Comparably’s Award for Best Company for Diversity 2022
• Winner of Comparably’s Award for Best Company for Women 2022
• Winner of Comparably’s Award for Best CEO 2022
• BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.
• Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.

Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace.  Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

Please click here to apply.