Associate II, Process Development (Cells CMC)

We are seeking an Associate II, Process Development (Cells CMC) to join Aspect’s  high-performing process development team focused on developing bioprinted tissue therapeutics for cell therapy applications. Reporting to the Manager, Process Development (Cells CMC), you will support the production, qualification, and scale-up of multiple cell lines to drive the development of bioprinted tissue therapeutics (BTT). Cell types will include partner-supplied iPSC β cell aggregates, type 1 diabetes (T1D) focused reporter cell lines (primary islets, MIN6,, etc.), and others. This is an onsite position, with an expectation to be in the laboratory at least 80% of the time.

Responsibilities

• Independently support the production and supply of various cell types to Aspect’s CMC and R&D groups for downstream bioprinting and assay development.
• Independently complete all stages of cell culture processing including thawing, expansion, media change, aggregation, cryopreservation, and banking.
• Assess and interpret in vitro viability and functional assays for cell characterization.
• Optimize and contribute to the scale-up processing of therapeutic cells.
• Contribute to the development of release Certificate of Analysis (CoA) for internal cell lines to document post-production characterization and ensure quality cell products.
• Complete internal IQ/OQ/PQ of new cell processing and manufacturing equipment.
• Work closely with R&D, CMC, quality, and regulatory teams to support non-GMP technology transfer(s) of culture processes in compliance with regulatory requirements.
• Perform data collection and analysis to contribute insights for cell culture process improvement.
• Assist with reagents and buffers preparation, and complete periodic inventory checks.
• Collaborate with cross functional teams (preclinical R&D, CMC, Therapeutic Cell Platforms) to refine bioprocessing methods.
• Create, review, and maintain documentation such as standard operating procedures (SOPs), Batch Production Records (BPRs), protocols, reagent preparation forms, and experimental reports in Good Documentation Practices (GDP).
• Develop subject matter expertise and work with other CMC teams to ensure technical compliance and adherence.

Qualifications                                                                         

• Education + Experience: BSc (with 2+ years of experience) or MSc in Cell Biology, Biotechnology, Biomedical Engineering, or a related field with demonstrated experience working aseptically with mammalian cell culture preferably in an industry setting. Experience in cGMP environment would be an asset.
• Beneficial Knowledge: Experience with immortalized insulinoma cell lines, primary or stem cell derived insulin-producing cells will be an asset. Experience with 3D, spheroid, organoid or hydrogel cell culture is an asset.

Who You Are                                                                          

• 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.
• Collaborative: You thrive in a multi-disciplinary 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.
• Detail-Oriented: You have outstanding attention to detail as well as experimental and process rigour. You take pride in your work and strive for excellence.
• Meticulously Organized: You can multitask, prioritize competing deadlines, and have a track record for delivering work on time.
• 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 $57,000-$82,000, 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.