Scientist, Process Development (Bioprinting CMC)

We are seeking a Scientist, Process Development (Bioprinting CMC) to join our high-performing team focused on the manufacturing and process development of bioprinted tissue therapeutics (BTT). In this role, you will support Aspect’s therapeutic programs by driving the production of various BTTs, directly contributing to Aspect’s groundbreaking programs and our mission development of bioprinted tissue therapeutics to transform the lives of people with serious diseases. 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

• Drive the manufacturing and development of BTTs in both in-vitro and in-vivo environments to support Aspect’s Good Manufacturing Practices (GMP) and research and development goals.
• Design and execute experiments to optimize bioprinting processes for production of BTTs.
• Collaborate extensively with Aspect’s Technical Operations, Research and Development, and Engineering teams to innovate, optimize, and translate laboratory -scale bioprinting processed to scalable manufacturing operations.
• Establish and perform rigorous testing and validation protocols for bioprinted constructs to ensure they meet predefined specifications for structure, function, and biological activity.
• Develop and characterize process parameters to ensure reproducibility, scalability, and quality of bioprinted constructs.
• Provide technical support for troubleshooting and root cause analysis during manufacturing deviations or process improvements.
• Ensure the preparation of materials and reagents for BTT processes adheres to Good Documentation Practices (GDP).
• Lead the development, characterization, and validation of bioprinting to meet project-specific and company-wide milestones.
• Support the maintenance and operational efficiency of bioprinting equipment, ensuring continuous and effective production workflows.
• Ensure that optimization and scaling strategies for BTT production align with current Good Manufacturing Practices (cGMP) regulations.
• Create, review, and maintain experimental forms, SOPs, Batch Production Records (BPRs), experimental report writing, and other essential documentation to support CMC and R&D activities.
• Ensure all processes and procedures are meticulously documented and comply with relevant regulatory and quality standards.
• Foster strong partnerships with internal teams and external experts to support the continuous improvement of bioprinting technologies and therapeutic applications.
• Act as a subject matter expert in bioprinting process development, providing insights and guidance to drive innovation and operational excellence.
• Present findings and progress reports to internal teams and external collaborators.

Qualifications                                                                         

• Education + Experience: A master’s in biomedical engineering, materials science, biochemistry, life sciences or related field, accompanied by a minimum of 5 years of industry experience; alternatively, a bachelor’s with at least 7 years of industry experience.
• Analytical Techniques and Proficiency: Skilled in mechanical testing, microscopy, and other assays with expertise in statistical process control methodologies.
• Design of Experiments (DOE): Experienced in utilizing DOE methodologies for process optimization and analysis.
• Preferred familiarity: Familiarity with 3D printing techniques, cell culture, and biomaterials is strongly preferred.
• Process Development Experience: Strong background in the development, scale-up, and optimization of biomanufacturing processes in a cGMP setting ideally in the cell therapy space.
• 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 $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.