Senior Scientist, Cryopreservation Process Development

We are seeking a Senior Scientist, Cryopreservation Process Development to join our dynamic Technical Operations team. In this pivotal role, you will develop and optimize packaging processes, with a key focus on cryogenic preservation, formulation, stability, and shipping logistics to ensure the integrity and viability of our BTTs across all stages of operation. The majority of your time will be spent in the lab, driving hands-on experimentation and analysis to refine and validate processes. Your contributions will be critical in advancing healthcare, driving the development of BTTs that have the potential to revolutionize the treatment of diseases previously deemed incurable.

Responsibilities

• Collaborate with R&D to design, execute, and interpret cryoformulation experiments to establish cryogenic preservation and cryogenic storage protocols that preserve the integrity of our BTT and integrate these into packaging designs tailored to BTT’s stability needs.
• Evaluate and optimize packaging materials and methods for cryogenic preservation in compliance with regulatory requirements and best practices in cryogenic storage and handling, ensuring product viability and process optimization for technology transfer.
• Design, execute, and interpret experiments to optimize freezing, thawing, and storage conditions for our BTT, ensuring maximum viability and potency of cells.
• Assess and optimize cryoprotectant formulations and freezing/thawing processes to enhance product survival and performance.
• Design, execute, and interpret stability studies to evaluate the effects of packaging on the shelf-life and functionality of the BTT.
• Develop shipping and packaging protocols that implement strategies to ensure BTTs reach their destination without loss of quality or functionality and mitigate degradation.
• Conduct risk assessments and failure mode analyses to identify and mitigate potential issues in packaging and shipping.
• Collaborate and manage external vendors and partners to source, evaluate, and review packaging materials and services ensuring alignment with Aspect’s quality standards and operational goals.
• Work closely with R&D, Quality Assurance and Manufacturing teams to align packaging processes with overall product development and commercialization goals.
• Prepare experimental designs, standard operating procedures, technical protocols, and reports in compliance with regulatory requirements while interacting in a cross-functional environment and prepare documentation for regulatory submissions and audits.
• Analyze scientific data to identify trends, drive improvements, and support decision-making.
• Maintain thorough documentation of packaging procedures, protocols, and validation processes.
• Prepare and present scientific data in internal and external forums on the performance and optimization of the packaging and transportation of BTTs.
• Stay abreast of advancements in cryogenic technology and industry best practices to drive innovation within Aspect technology operations team.

Qualifications

• Education + Experience: A doctorate in biomedical engineering, materials science, biochemistry, life sciences or related field, accompanied by a minimum of 5 years of industry experience; alternatively, a master’s with at least 9 years of industry experience.
• Process Development Experience: Strong background in the development and optimization of packaging processes ideally in the cell therapy space. Specializing in cryopreservation techniques, formulation stability studies, and extensive knowledge of packaging technologies and materials for biological products.
• GMP & GDP Knowledge: Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Who you are

• Problem Solver: You love immersing yourself in difficult technical problems and coming up with solutions that work. You think outside the box and use your experience and intuition to identify when such solutions are realistic.
• Detail-Oriented & Meticulously Organized: You have outstanding attention to detail and take pride in your work. You can multitask, prioritize competing deadlines, and have a track record for delivering work on time.
• Thrive in Ambiguity: You are highly adaptable, agile, and poised when faced with change, ambiguity and competing priorities.
• Collaborative: You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.
• Effective Communicator: You are an active listener who can effectively communicate to different audiences in diverse situations.
• Go-Getter: You work with a sense of urgency, are results-driven, and thrive in a fast-paced, interdisciplinary and entrepreneurial environment. You are willing to roll up your sleeves and do what it takes to get the job done.

The hiring range for this role is $103,000 - $147,000 CAD, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.