We are seeking an Associate II, Quality Control to join our dynamic team dedicated to advancing assay development and characterizing bioprinted tissue therapeutics for cell therapy applications. In this role, you will be responsible for developing and conducting routine raw material testing, performing biological and mechanical analytical assays, contributing to the development and validation of new assays, and providing support to our R&D, Process Development, and Bioprinting Teams in characterizing drug substance, drug product, and final product. This is an onsite position.

Responsibilities

• Support studies to assess iPSC β-cell aggregates, primary pancreatic islets, primary hepatocytes, and cell lines (Min6, Ins1, HepG2, etc.) viability in vitro and ex vivo, including the development of quantitative measures for cell viability, purity, and potency.
• Execute routine analytical assays such as ELISA, fluorescent microscopy, cytotoxicity, osmolality, viscosity, purity, rheology, and other QC Analytics functions as needed.
• Design and execute raw material and stability testing programs in coordination with quality assurance and other stakeholders.
• Help develop methods to support biomaterial QC activities such as material release and generation of Certificates of Analysis.
• Perform laboratory-based studies to qualify biocompatible materials for incorporation into bioprinted pancreatic tissues.
• Provide support towards process optimization and scale-up activities to enable progress toward IND submission for multiple bioprinted tissue therapeutic product candidates.
• Participate in assay development and validation activities for R&D and manufacturing purposes.
• Support technology transfer of analytical assays out of and into the QC Analytics team.
• Participate in laboratory and product excursion investigations (Alert, Action, and Out of Spec/Out of Trend) in coordination with Quality Assurance.
• Conduct peer review of analytical data, maintain data trending records, and execute statistical process control methods to evaluate cells, clusters, islets, and bioprinted tissue therapeutics throughout the manufacturing process.
• Develop subject matter expertise and work with process development and manufacturing teams to ensure technical compliance and adherence.
• Support development and execution of drug substance/product process optimization and characterization projects to achieve specific project and company milestones.
• Support the production and assessment of bioprinted tissue therapeutics to Aspect’s R&D and Manufacturing groups. Duties may include equipment readiness and maintenance as well as product monitoring.
• Work with the Aspect’s Manufacturing, R&D, and Engineering teams to generate, optimize, and characterize analytical assays which are suitable for specific tissues/indications.
• Execute cGMP compliant documentation of analytical assays, primary/stem cell manufacturing, and biomaterial development activities in compliance with Good Documentation Practices (GDP).
• Create and maintain SOPs, batch records, and other documentation as required in compliance with GDP.
• Develop experimental protocols, update experimental reports, and present experimental data to key stakeholders.

Qualifications

• Education Experience: A master’s in biomedical engineering, materials science, biochemistry, life sciences or related field, accompanied by a minimum of 2 years of industry experience; alternatively, a BSc. with at least 5 years of industry experience.
• Professional Experience. Moderate experience in raw material testing, development of stability programs, and assay development within a GLP/GDP environment. Additional expertise in aseptic mammalian cell culture, and bioanalytical quantification assays including ELISA is considered an asset. Experience with adherence to GLP/GDP practices.
• Strong Analytical Skills: Proficiency in analyzing datasets to interpret and communicate findings to key stakeholders

Who You Are

• Detail-Oriented: You have outstanding attention to detail and exhibit experimental and process rigour. You take pride in your work and strive for excellence.
• Meticulously Organized: You can multi-task, prioritize competing deadlines, and have a track record for delivering work on time.
• Collaborative: You thrive in a multidisciplinary team environment and believe that we can get further, faster, by working together. You take direction well and ask for clarification when necessary.
• Effective Communicator: You are an active listener who can communicate to different audiences in diverse situations.
• Critical Thinker: You excel at evaluating difficult challenges, seeking input from different sources, and contributing to well-informed decisions.

The hiring range for this role is $47,000 - $67,000, 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.