Scientist, Process Development (Cells CMC)

We are seeking a Scientist to join Aspect’s Process Development (Cells CMC) team. Reporting to the Manager, Process Development (Cells CMC), you will optimize immortalized, primary, and stem cell manufacturing processes for bioprinted tissue therapeutics (BTT). The focus will be on process development for robust, scalable, and compliant cell processes to support Aspect’s research and development goals. This role requires extensive collaboration across multidisciplinary teams to advance therapeutic cell development for bioprinting while ensuring adherence to regulatory and quality standards. Majority of the time for this role will be spent in the lab, where you will lead hands-on experimentation, cell production, optimize cell culture processes, cell characterization, troubleshoot challenges, and design processes that deliver reproducible outcomes aligned with Aspect’s mission to transform lives through bioprinted therapeutics.

Responsibilities

• Design, execute, and analyze experiments to develop and optimize cell culture processes at all stages of unit operations, including thawing, expansion, aggregation, cryopreservation and banking, media optimization, feeding strategies, and bioreactor operations.
• Scale up cell production from bench to pilot manufacturing while maintaining robust and reproducible critical quality attributes (CQAs).
• Onboard new cell lines to support various in vitro and in vivo studies by establishing cell culture and maintenance protocols.
• Evaluate new cell lines for bioprinting development and functionality.
• Lead the production and supply of various cell types to Aspect’s CMC and R&D groups for downstream bioprinting development.
• Develop release Certificate of Analysis (CoA) for internal cell lines to document post-production characterization and ensure quality cell products.
• Use statistical tools to analyze experimental data, identify critical process parameters (CPPs), and refine processes.
• Prepare detailed technical reports, protocols, and presentations to communicate findings internally and externally.
• Work closely with R&D, CMC, quality, and regulatory teams to lead seamless non-GMP technology transfer(s) of cell isolation and/or culture processes in compliance with regulatory requirements.
• Collaborate with analytical development teams to integrate in-process monitoring and quality control assays into cell culturing workflows.
• Create, review, and maintain documentation such as SOPs, Batch Production Records (BPRs), reagent preparation forms, and experimental reports in Good Documentation Practices (GDP).
• Develop and execute validation protocols for cell-based processes, supporting manufacturing troubleshooting and root cause analysis.
• Act as a subject matter expert in cell-based process development and production, contributing insights to drive innovation and operational excellence.
• Evaluate and implement new technologies to enhance process scalability and performance.
• Complete internal IQ/OQ/PQ of new cell processing and manufacturing equipment.
• Train team members on new processes and technologies, fostering continuous professional growth and adherence to quality standards.
• Partner with Quality Assurance and regulatory teams to ensure cell-based processes meet required standards.
• Contribute to regulatory filings by providing process descriptions, experimental data, and supporting documentation.
• Represent the Process Development (Cells CMC) team in cross-functional meetings and projects to align strategies and achieve organizational goals.
• Work closely with biologists, biomaterial scientists and engineers to optimize bioprinted tissue performance.

Qualifications                                                                                    

• Education: PhD in Cell Biology, Biotechnology, Biomedical Engineering, or a related field, or MSc with 5+ years of relevant industry experience.
• Experience: Expertise in mammalian cell (e.g. immortalized, primary, stem) culture processes, with experience in cell aggregation, and scaling to GMP manufacturing. Proficiency in bioreactor systems, cell culture automation, and process optimization and closure are a bonus.
• Technical Skills: Strong statistical analysis and experimental design skills. Familiarity with analytical methods (e.g. counting, microscopy, aggregate sizing, flow cytometry, immunofluorescence staining, ELISA, qPCR, etc.). Experience with Design of Experiments (DoE).
• Preferred GXP Knowledge: Understanding of GMP, GDP, and regulatory requirements for cell-based therapeutics is a strong asset.
• Project Management: Proven ability to manage multiple projects with competing deadlines in a fast-paced environment.

Who You Are                                                                                    

• Intellectually Curious: You have a burning desire to learn more and aren’t afraid to ask questions.
• 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 $77,000 - $110,000, 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.