We are seeking a Scientist, Process Development, Bioprinted Tissue Therapeutic (BTT) 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 bioprinted tissue therapeutics that have the potential to revolutionize the treatment of diseases previously deemed incurable.

Responsibilities

• Design, develop, and implement manufacturing processes and packaging solutions such as cryogenic preservation and storage protocols for our BTT.
• Support manufacturing of BTTs in-vitro and in-vivo for Aspect’s Research and other Development groups.
• Collaborate with Research and Development to create 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, ensuring product viability and process optimization for technology transfer.
• Conduct experiments to optimize freezing, thawing, and storage conditions, ensuring maximum viability and potency of cells.
• Assess and improve cryoprotectant formulations and freezing/thawing processes to enhance product survival and performance.
• Ensure compliance with regulatory requirements and best practices in cryogenic storage and handling.
• Conduct stability studies to evaluate the effects of packaging on the shelf-life and functionality of BTT.
• Analyze process data to identify trends, drive improvements, and support decision-making.
• Implement strategies to mitigate the degradation of BTT during storage and transit.
• Develop shipping and packaging protocols that ensure BTT’s reach their destination without loss of quality or functionality.
• Ensure compliance with regulatory requirements and prepare documentation for regulatory submissions and audits.
• Conduct risk assessments and failure mode analyses to identify and mitigate potential issues in packaging and shipping.
• Maintain thorough documentation of packaging procedures, protocols, and validation processes.
• Work closely with R&D, Quality Assurance, and Manufacturing teams to align packaging processes with overall product development and commercialization goals.
• Collaborate with external vendors and partners to source and evaluate packaging materials and services.
• Manage contracts and performance reviews of external vendors, ensuring alignment with Aspect’s quality standards and operational goals
• Provide technical support and training to internal teams on packaging protocols and procedures.
• Prepare and present reports to senior management on the performance and optimization of the packaging and transportation of bioprinted tissue therapeutics
• Stay abreast of advancements in cryogenic technology and industry best practices to drive innovation within Aspect technology operations team.

Qualifications

• Education + Experience: A PhD in biomedical engineering, materials science, biochemistry, life sciences or related field, alternatively, a MSc with at least 5 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 $81,000 - $116,000 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.