Aurion Biotech Inc.

Biotechnology51-200 employeesWebsite

3

Open Roles

Aurion Biotech Inc. is a clinical-stage biotechnology company with a mission to restore vision to millions of patients through regenerative therapies. Based in the biotechnology industry, Aurion Biotech has a company size of 51-200 employees. The company has offices in Seattle, Boston, and Tokyo. Aurion Biotech Inc. is currently hiring for three positions: **1. Process Engineer I, MSAT/ExM:** This hybrid role in Cambridge, MA, reports to the Director, Manufacturing. The salary range is $85,000 to $101,000 USD. The Process Engineer I will provide technical oversight of a late-stage combination cell therapy product, focusing on site readiness, cleanroom expansions, tech transfer, risk assessments, regulatory document submissions, comparability/validation campaigns, and ongoing process support for late-stage clinical and commercial manufacturing. Key responsibilities include supporting tech transfer activities and GMP operations, participating in site readiness activities, supporting GMP manufacturing execution, creating technical documents, providing input on process support playbooks, supporting deviation and change control assessments, collaborating with manufacturing sites, contributing to validation activities, supporting manufacture data capture, performing hands-on training, and ensuring cross-functional alignment. A B.S, M.S, or Ph.D. degree in a scientific or engineering discipline is required. B.S. with 3-5 years or M.S. with 0-2 years of experience in MS&T, External Manufacturing or Process Development for biologics/cell therapies is needed. Travel required up to 40%. **2. Process Engineer II, MSAT/ExM:** Also a hybrid role in Cambridge, MA, the Process Engineer II reports to the Director, Manufacturing. The salary range is $112,000 to $123,000 USD. This position involves technical oversight of a late-stage combination cell therapy product and focuses on site readiness, cleanroom expansions, tech transfer, risk assessments, submission of regulatory documents, comparability/validation campaigns, and ongoing process support for late-stage clinical and commercial manufacturing. Key responsibilities include supporting tech transfer activities and GMP operations, participating in new site/suite readiness activities, supporting GMP manufacturing execution, developing and maintaining relationships with internal and external partners, supporting authoring and review of CMC sections for health authority submissions, owning and supporting key technical document creation, creating process support playbooks, driving deviation and change control assessments, collaborating with manufacturing sites, contributing to validation activities, supporting manufacture data capture, performing hands-on training, ensuring cross-functional alignment, and monitoring Drug Substance and Drug Product performance metrics. A B.S, M.S, or Ph.D. degree in a scientific or engineering discipline is required. B.S. with 5-7 years or M.S. with 3-5 years of experience in MS&T, External Manufacturing or Process Development for biologics/cell therapies is required. Travel required up to 40%. **3. Scientist, Process Sciences:** This on-site position is located in Cambridge, MA, with a salary range of $85,000 to $101,000 USD. The Scientist, Process Sciences, will work on scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. This role analyzes data sets from Process Development and manufacturing, investigates non-conformance results, creates presentations, authors/maintains technical reports, and collaborates with cross-functional teams. A Bachelor’s degree in a scientific discipline is required. 2-5 years of experience in the pharmaceutical or biotechnology industry within a GMP environment is also required. 10% travel is expected. The company utilizes various technologies. The job descriptions mention these technologies for different roles: Process Development, GMP Manufacturing, Tech Transfer, Validation, Risk Assessment, Troubleshooting, Analytical Skills, Communication, Interpersonal Skills, Problem Solving, Data Analysis, Collaboration, Regulatory Compliance, Manufacturing Improvement, Cell Therapies, Biologics, Mammalian Cell Culture, Cellular Metabolism, Statistics, Technical Reporting, Continuous Improvement, Scale-Up, Biologics Processes, Root Cause Analysis, Presentation Skills, and Teamwork. Aurion Biotech offers a hybrid work environment for some positions, with the Process Engineer I and Process Engineer II roles in Cambridge, MA, following this policy. The Scientist, Process Sciences role is on-site in Cambridge, MA. 1. **What benefits does Aurion Biotech offer?** Aurion Biotech offers full health insurance to employees and their families, 401(k) matching, an EAP, FSA, and generous PTO. 2. **Where are the job locations?** The company has job openings in Cambridge, MA. 3. **What are the required educational qualifications for the Process Engineer I and Process Engineer II positions?** A B.S, M.S, or Ph.D. degree in a scientific or engineering discipline is required. 4. **What kind of experience is preferred for the Scientist, Process Sciences role?** Experience in tech transfer, scale-up, and cell therapy/biologics processes is highly preferred. 5. **Is travel required for these positions?** Travel is required up to 40% for the Process Engineer I and Process Engineer II positions.