Associate, Process Development (Cells)
Job Description
<p>We are seeking a highly enthusiastic Associate, Process Development (Cells) to join our process development team focused on developing bioprinted tissue therapeutics for cell therapy applications. You will support the production, qualification, and scale-up of multiple cell lines to drive the development of bioprinted tissue therapeutics (BTT). You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. </p> <p><strong>Responsibilities</strong></p> <ul> <li>Independently support the production and supply of various cell types to Aspect’s CMC and R&D groups for downstream bioprinting and assay development.</li> <li>Independently complete all stages of cell culture processing including cell isolation from cadaveric tissue, cell thawing, expansion, media change, aggregation, cryopreservation, and banking.</li> <li>Assess and interpret in vitro viability and functional assays for cell characterization.</li> <li>Optimize and contribute to the scale-up processing of therapeutic cells.</li> <li>Contribute to the development of release Certificate of Analysis (CoA) for internal cell lines to document post-production characterization and ensure quality cell products.</li> <li>Complete internal IQ/OQ/PQ of new cell processing and manufacturing equipment.</li> <li>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.</li> <li>Perform data collection and analysis to contribute insights for cell culture process improvement.</li> <li>Assist with reagents and buffers preparation, and complete periodic inventory checks.</li> <li>Collaborate with cross functional teams (preclinical R&D, CMC, Therapeutic Cell Platforms) to refine bioprocessing methods.</li> <li>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).</li> <li>Develop subject matter expertise and work with other CMC teams to ensure technical compliance and adherence.</li> </ul> <p><strong>Qualifications & Experience</strong></p> <ul> <li><strong>Education + Experience: </strong>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.</li> <li><strong>Knowledge: </strong>Experience with cell isolation from human or animal tissue, 3D cell culture, primary cell culture, immortalized insulinoma cell lines, primary or stem cell derived insulin-producing cells will be an asset.</li> <li><strong>Go-Getter: </strong>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.</li> <li><strong>Collaborative: </strong>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.</li> <li><strong>Effective Communicator: </strong>You are an active listener who can communicate to different audiences in diverse situations.</li> </ul> <p>The hiring range for this role is $64,000 - $72,000, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but no