- Design, develop and optimize analytical methods to support iPSC cell banking and cell therapy manufacturing processes with a focus on genomic characterization methods.
- Ensure that 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.
- Act as subject matter experts to plan and execute analytical method transfers with upstream (Research) and downstream (Quality Control) analytical teams; qualify assays as appropriate and provide training and further qualification/validation support as needed.
- Champion evaluating and implementing new technologies and analytical methods to characterize PSC starting materials and differentiated drug substances.
- Analyze experimental data to draw conclusions that support decision making and next steps within and across projects.
- Perform other cellular and/or molecular assays as required.
- Prepare and present project plans and regular project progress updates and recommendations.
- Document experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system.
- Prepare, review, and approve experimental protocols, reports, standard operating procedures and other scientific and quality documents.
- Requires hands-on laboratory work in addition to training and supervision of junior staff members in supporting analytical activities within the AD team.
- Identify and evaluate new technologies and incorporate them into product quality assessments as appropriate.
- 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.
- Contribute to building a culture that embraces scientific excellence, integrity, urgency, courage, and community.
- Degree in biological sciences, or similar with 2+ (PhD) or 11+ (MSc) years or 12+ (BSc) of relevant experience, preferably in an industry environment.
- Significant hands-on experience in developing and optimizing genomic characterization methods, such as droplet digital PCR (ddPCR), whole genome sequencing (WGS), optical genome mapping (OGM), fluorescence in situ hybridization (FISH) and/or SNP arrays.
- Experience in clinical cytogenetics is an asset.
- Hands-on experience in mammalian cell culture is required.
- Strong preference for experience in the Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing.
- Experience with automated liquid handlers is an asset.
- Practical knowledge of statistical analysis of data is required.
- Knowledge and understanding of statistical programming languages (R, python, etc.) and Design of Experiments (DoEs) is preferred.
- Proven ability to structure, plan, and execute experiments and independently execute complex tasks in a fast-paced environment.
- Excellent organizational and problem-solving skills, with demonstrated ability to work cross-functionally.
- Proficiency in technical scientific writing.
- Excellent interpersonal, verbal and written communication skills.
- Experience with GxP guidelines/documentation and general GxP experience in analytical development is an asset but not required. #LI-AL1
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Scientist II Analytical Development - Toronto, Canada - BlueRock Therapeutics
Description
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.The Toronto, ON site is seeking a Scientist II to join our Analytical Development team. As a central development resource at the company, the Analytical Development team works closely with research, process development, non-clinical and clinical development, manufacturing and quality teams. The successful candidate will be a key scientific contributor and technical leader as part of the larger Technical Operations organization in a dynamic and progressive team developing industry-leading cell-based analytics to characterize cell therapy products and manufacturing processes.Responsibilities:
Minimum Requirements:
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