Senior Engineer, MSAT

JOB TITLE: Senior Engineer, MSAT

LOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS or WA.

SALARY RANGE: $140,000 to $164,000

REPORTS TO: Director, MSAT

ABOUT THE POSITION

Aurion Biotech is a rapidly growing biotech focused on developing innovative cell therapies to treat ocular diseases. We are looking for a Senior Engineer, MSAT to support technology transfers and commercial readiness of late-stage cell therapy products at external manufacturing sites.

This role independently supports and may lead complex technical workstreams supporting new site and suite readiness, technology transfer, feasibility and engineering runs, process implementation, risk assessments, GMP manufacturing support, comparability and validation activities, and ongoing process performance monitoring. The Senior Engineer serves as a technical and GMP manufacturing SME within assigned process areas and works closely with CDMOs and cross-functional partners to successfully transfer established manufacturing processes into compliant, robust, and sustainable commercial operations. If you are a highly motivated and experienced GMP manufacturing professional with a passion for network expansion and commercializing innovative drug therapies, we encourage you to apply for this exciting opportunity to join our team.

KEY RESPONSIBILITIES

• Independently executes and supports technology transfer workstreams for late-stage clinical and commercial manufacturing sites, including transfer planning, process implementation, site readiness, training, and execution.
• Independently executes and supports and may lead new site and suite readiness assessments, including facility fit and feasibility risk assessments, technical risk assessments, equipment readiness, process fit, personnel readiness, and process documentation.
• Author and support execution of technology transfer documentation, protocols, risk assessments, batch records, troubleshooting guides, process playbooks, change controls, training materials, etc. 
• Collaborate with manufacturing sites and CDMOs to ensure technology, equipment, materials, personnel, procedures, and documentation are in place to support compliant and reliable GMP manufacturing. 
• Provide on-site Person-in-Plan (PiP) technical support during feasibility, engineering, GMP, comparability, and validation campaigns; troubleshoot manufacturing issues and support timely resolution of technical problems, and GMP deviations.
• Identify and lead continuous improvement opportunities from form, fit, function risk assessments, to initiate change controls, to author transfer packages, and through to implementation at GMP manufacturing sites.
• Independently executes and supports implementation of process knowledge and the process control strategy at receiving manufacturing sites, including CPPs, CQAs, in-process controls, operating ranges, monitoring requirements, and escalation criteria.
• Establish manufacturing data capture and trending during technology transfer and transition to routine manufacturing. Perform statistical analysis using JMP or similar tools to evaluate process performance, variability, trends, and shifts.
• Ensure cross-functional alignment with Process Development, Process Sciences, External Manufacturing, Manufacturing Validations, Quality, Regulatory, and Supply Chain to execute tech transfers and implement process improvements.
• Other duties as assigned.

ABOUT AURION BIOTECH 

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values: 

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company. 
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate. 
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments. 

Aurion Biotech has a lot to accomplish in the next few years, and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com.

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• B.S, M.S, or Ph.D. degree in a scientific or engineering discipline required.
• 7+ years of relevant industry experience w/ a B.S.; 4+ years of experience w/ M.S. or PhD
• At least 3+ years of experience in MS&T, Manufacturing or Process Development for biologics/cell therapies; working effectively across cross-functional teams, coordinate activities with external partners and CDMOs, take ownership and independent execution of assigned deliverables, and contribute to problem-solving in a dynamic environment
• Experience with late-stage clinical, BLA-enabling, or commercial manufacturing activities required. Experience with multiple commercial manufacturing facilities and multiple commercial cell therapy products, a plus.
• Experience supporting or leading technology transfers for biologics, cell therapies, or other complex manufacturing processes.
• Experience working directly with CDMOs or external manufacturing sites during technology transfer and/or GMP manufacturing.
• Solid understanding of cGMP regulations, ICH guidelines, and regulatory expectations for biologics or cell therapy manufacturing.

REQUIRED SKILLS AND ABILITIES

• Strong technical writing skills with experience authoring and reviewing protocols, reports, risk assessments, batch records, technical assessments, and source documents supporting regulatory filings.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
• Background in cell therapy, viral vector, or other complex biologic modality with GMP manufacturing and PiP experience.
• Demonstrated ability to independently own technical projects and workstreams with minimal day-to-day supervision.
• Experience conducting or facilitating technical, process, facility-fit, and manufacturing risk assessments using tools such as FMEA or similar risk-management methodologies.
• Strong analytical and problem-solving skills and process troubleshooting with a data-driven mindset.
• Expertise in deviation management, change control, and CAPA.
• Hands-on experience with cell culture manufacturing, including cell expansion, harvest, cryopreservation, and aseptic processing a plus.
• Proficiency with Microsoft Office tools and data analysis platforms (e.g., JMP, Excel).
• Travel required up to 35%.