Associate Director, MSAT - Aurion Biotech : Job Details

Fully Remote • US Remote - WA, NM, SD, TX, IN, SC, NC, PA, NY, NH, KY or MA applicants only

Job Type

Full-time

Description

JOB TITLE: Associate Director, MSAT – Vertical Lead

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

SALARY RANGE: $175,000 to $195,000. The midpoint of the range is $187,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

Aurion Biotech is expanding its Manufacturing function and establishing focused “verticals” to drive late-stage clinical and commercial success. Reporting to the Executive Director of Manufacturing, the Associate Director, MSAT – Vertical Lead will be responsible for the technical oversight of a late-stage combination cell therapy product, focusing on site readiness, new cleanroom expansions, tech transfer, feasibility runs, engineering campaigns, and ongoing process support of late stage clinical and commercial manufacturing. You will serve as the MSAT lead for new site onboarding and GMP-readiness, ensure successful process transfer and scale-up, troubleshoot operational challenges, and lead cross-functional initiatives that support robust and compliant manufacturing. You will manage MSAT at all manufacturing sites and the functional vertical to ensure that our cell-therapy products are reliably transferred, continuously improved, and fully compliant with global regulatory expectations. Your peers will be External Manufacturing and Manufacturing Validation vertical leads. If you are a highly motivated, experienced cell therapy GMP professional with experience managing new manufacturing site onboarding and tech transfer and a passion for developing innovative cell therapies, we encourage you to apply for this exciting opportunity to join our team.KEY RESPONSIBILITIES

• Build and lead MSAT vertical, serve as MSAT lead for one or more manufacturing sites supporting late-stage clinical or commercial programs
• Lead new site readiness activities, including facility fit assessments, tech transfer planning, and execution of feasibility and engineering runs
• Support GMP manufacturing execution, including on-site presence during initial campaign activities, troubleshooting issues, and driving investigations to closure
• Own or support creation of key technical documents, including tech transfer plans, batch records, risk assessments, deviation analyses, and change controls
• Create process support playbooks and troubleshooting guides
• Drive deviation and change-control impact assessments, ensuring robust root-cause analysis and timely closure of GMP investigations
• Collaborate with manufacturing sites to ensure technology, equipment, and documentation are in place to support compliant and efficient manufacturing
• Contribute to validation activities (e.g., engineering runs, PPQ support, process characterization data) and help define control strategies
• Establish manufacture data capture for trending and CPV
• Ensure cross-functional alignment with Process Development, Process Sciences, External Manufacturing, Quality, Regulatory, and Supply Chain to execute tech transfers and implement process improvements
• Monitor Drug Substance and Drug Product performance metrics and recommend improvements in process consistency, yield, or compliance
• 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. in a scientific or engineering discipline
• Experience in late-stage or commercial cell and gene therapy required. Experience with multiple commercial cell therapy products, a plus
• Hands-on experience with new site initiations, tech transfer, scale-up, feasibility runs, comparability or validation activities for cell therapy or complex biologics
• 8+ years of experience in Manufacturing, MSAT, or Process Development for biologics/cell therapies; 3+ years leading cross-functional teams or direct reports
• Experience supporting or leading CDMO partnerships for cell therapy or other advanced biologic modalities clinical or commercial supply
• Experience authoring and defending CMC sections of regulatory submissions
• Working knowledge of GMPs, ICH guidelines, and regulatory expectations for cell therapies

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Background in cell therapy, viral vector, or other complex biologic modalities highly preferred
• Demonstrated track record managing new site tech transfers to enable manufacturing product in a fast-paced, evolving environment
• Strong analytical and problem-solving skills with a data-driven mindset.
• Expertise in deviation management, change control, and CAPA
• Strong technical writing and document review capabilities
• Skilled in problem-solving, process troubleshooting, and data analysis
• Collaborative and agile with the ability to work effectively in cross-functional teams
• Excellent communication and organizational skills; able to manage multiple priorities
• Proficiency with project management tools and data analysis platforms (e.g., JMP, Excel)
• Passion for mentoring and developing junior staff and fostering a culture aligned with Aurion Biotech values (Stewardship, Transformation, Grit)