Associate, Process Development (Bioprinting)

We are seeking an Associate, Process Development (Bioprinting CMC) to join our high-performing team focused on the manufacturing and process development of bioprinted tissue therapeutics (BTT). Reporting to the Senior Manager, Process Development, you will support our therapeutic programs by assisting in the production of various BTTs, directly contributing to our groundbreaking programs and our mission to develop bioprinted tissue therapeutics to transform the lives of people with serious diseases.

Responsibilities

• Supporting in the manufacturing of BTTs in-vitro and in-vivo for Good Manufacturing Practices (GMP) and research and development goals.
• Preparing materials and reagents for BTT processes in compliance with Good Documentation Practices (GDP).
• Helping carry out process optimization and scale up activities to support IND-enabling work for multiple BTT product candidates.
• Performing routine maintenance of bioprinting equipment to support consistent production.
• Assisting in developing and testing bioprinting processes and BTTs to meet project goals.
• Following standard operating procedures (SOPs) and collaborating with process development teams to ensure compliance.
• Ensuring compliance of optimization and scaling strategies with cGMP regulations.
• Working closely with R&D, CMC, quality, and regulatory teams to support Bioprinting Design Transfers (BDT) in compliance with regulatory requirements.
• Designing and executing studies to qualify and characterize new BTTs.
• Performing data collection and analysis to contribute insights for process improvement.
• Collaborating cross functionally to help develop and refine bioprinting methods for different therapeutic applications.
• Creating and following experimental forms, SOPs, batch production records (BPRs), and other documentation as needed.

Qualifications                                                                         

• Education + Experience: A master’s in biomedical engineering, materials science, biochemistry, life sciences or related field; alternatively, a bachelor’s with 1 - 2 years of industry experience. 
• Process Development Exposure: Familiarity with biomanufacturing process development, including scale-up and optimization. Experience in a cGMP setting, especially in cell therapy would be highly beneficial.
• GMP & GDP Knowledge: Basic understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), with experience working in regulated environments. 
• 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 $64,000 - $72,000, 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.