Scientist II, Assay Development (Flow Cytometry)
BlueRock Therapeutics, Toronto, Canada
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.
Description of Position:
As part of BlueRock Therapeutics vision to change the future of medicine by enabling ground-breaking cell therapies, the candidate will be a key technical contributor of a dynamic and progressive team pioneering scaled somatic cell manufacturing processes utilizing state-of-the-art culturing technology at increasing scales.
The successful candidate will drive assay development at BlueRock, establishing critical flow cytometry and other cellular assays for cell therapy products and manufacturing processes. Extensive expertise in developing and qualifying multiparameter flow cytometry assays is required. The ideal candidate will be a highly motivated individual who leads from the bench and enjoys having broad responsibilities and opportunities. Collaboration with a highly motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for motivated, self-starting candidates. Familiarity with developing and qualifying assays under GLP or GMP regulations is a plus.
- Design and execute in vitro experiments to assess, develop and optimize novel multiparameter flow cytometry assays to characterize cell therapy manufacturing processes.
- Champion assessing, designing, developing, evaluating and implementing novel cytometric technologies, processes and methods to improve understanding of therapeutic cell product candidates and other material critical to safety and quality of drug substance and drug product for use in patients.
- Identify and determine appropriate ranges of (critical) assay process parameters to ensure robust, repeatable and accurate results with minimal supervision
- Ensure that experiments, analytical methods and data meet the requirements for the intended use of assays, which includes characterization, lot release and comparability.
- Perform other cellular and molecular assays as required.
- Collect and analyze data from various assays, track and trend data and establish specifications for critical process controls.
- Document experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system.
- Author and review SOPs, study protocols, reports and other scientific and quality documents.
- Ensure that assays meet regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System.
- Identify and evaluate new technologies and incorporate them into product quality assessments as appropriate.
- Qualify assays for use as Quality Control tools. Perform technology transfer of qualified assays to the Quality Unit through training of personnel and support of further qualification/validation efforts.
- This position requires hands-on laboratory work as well as supervision of research associates and technicians.
- Present scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications) as required.
- Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned.
- Excellent interpersonal, verbal and written communication skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization
- Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes
- Ph.D. in Biological Sciences and a minimum of two (2) years of relevant flow cytometry experience, or Master’s in Biological Sciences and a minimum of eleven (11) years of relevant flow cytometry experience, preferably in a contract research organization, biotechnology or pharmaceutical company, or similar industry environment.
- Demonstrated expertise with multiparameter flow cytometry procedures and data analysis software (e.g. FlowJo) including experience with operation, maintenance and daily calibration of cytometers
- Significant experience in developing, optimizing and qualifying multiparameter flow cytometry panels is required
- Practical understanding of qualification and/or validation of analytical assays (e.g. to GLP or GMP regulations) and familiarity with Good Documentation Practices is a strong plus
- A solid understanding of aseptic techniques and technologies in cell culture is required
- Experience in statistical analysis of data is desired
- Cooperating with a larger team, must be able to solve a wide range of complex problems in creative and practical ways
- Skilled in initiating and managing projects of complex scope, including cross-functions
- A proven ability to be highly productive and successful in a high pace work environment with excellent attention to details and meticulous bench work
- Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint)