Director, External Manufacturing - Aurion Biotech : Job Details

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

Full-time

Description

JOB TITLE: Director, External Manufacturing

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: $217,000 to $242,000. The midpoint of the range is $228,000. 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 Director, External Manufacturing – Vertical Lead will own a discrete portfolio of CDMO relationships and associated manufacturing programs, providing strategic direction and hands-on technical leadership from cleanroom initiation through routine GMP production and lifecycle management. You will manage manufacturing at all CDMOs and the functional vertical to ensure that our cell-therapy products are reliably manufactured and supplied, continuously improved, and fully compliant with global regulatory expectations. This role requires both strategic vision and day-to-day execution—to ensure Aurion's ambitious clinical and commercial timelines are met. Your peers will be the MSAT and Manufacturing Validation vertical leads. If you are a highly motivated, experienced GMP manufacturing professional with experience managing CDMOs 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 an ExM vertical responsible for all late-phase clinical or commercial CDMOs manufacturing execution, including hiring, mentoring, and performance management of direct reports.
• Deliver execution of continuous cell product manufacturing, resupply of small molecule, and right first time execution of GMP comparability and validation (PPQ) runs.
• Own CDMO relationships within the vertical: oversee manufacturing operations, PIPs, scheduling, deviations, continuous improvement implementation, operations optimization, and clinical and commercial manufacturing execution to deliver on supply.
• Establish key performance indicators (KPIs) for CDMOs and internal teams; monitor performance, implement corrective actions, and report metrics to leadership.
• Ensure cGMP compliance by maintaining up-to-date procedures, training, and audit readiness across internal teams and CDMOs.
• Partner with Process Development, Process Sciences, MSAT, Quality, Regulatory, and Supply Chain to implement process improvements and maintain an effective process-control strategy.
• Serve as Manufacturing Facility Lead in regulatory filings (e.g., IND amendments, BLA, MAA) for manufacturing activities under your vertical.
• Foster a culture of data-driven decision making, continuous improvement, and compliance across internal teams and CDMOs.
• Perform other duties as assigned to meet program and company objectives.

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.

Requirements

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
• 10+ years of experience in Manufacturing, MSAT, or Process Development for biologics/cell therapies; 4+ years leading cross functional teams or direct reports.
• Experience in late-stage or commercial cell and gene therapy required. Experience with multiple commercial cell therapy products, a plus. Experience with small molecule manufacturing and combination products, a plus.
• Demonstrated success managing CDMO partnerships and delivering clinical/commercial supply.
• Proven track record managing CDMOs, executing tech transfers, scale ups, comparability studies, and PPQ for cell therapy or other advanced biologic modalities.
• Experience authoring and defending CMC sections of regulatory submissions.
• Solid understanding of cGMP regulations, ICH guidelines, and global regulatory expectations for biologics.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Background in cell therapy, viral vector, or other complex biologic modalities highly preferred. Background in small molecule and RSM experience highly preferred.
• Demonstrated track record managing CDMOs and teams to manufacture product in a fast-paced, evolving environment.
• Strong analytical and problem solving skills with a data driven mindset.
• Expertise in deviation management and operational excellence.
• Excellent leadership, communication, and interpersonal skills—capable of influencing at all organizational levels and with external partners.
• Proficiency with project management and data analysis tools (e.g., MS Project, JMP, Minitab).
• Ability to thrive in a fast paced, rapidly evolving environment and meet aggressive timelines.
• Passion for mentoring and developing junior staff and fostering a culture aligned with Aurion Biotech values (Stewardship, Transformation, Grit).