Senior CMC Project Manager

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

DESCRIPTION

JOB TITLE:
Senior CMC Project Manager

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

SALARY RANGE: $142,000 to $170,000

Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. Our lead candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and it is advancing into Phase 3 clinical trials in 2025.

Aurion operates as a separate entity with full support from Alcon.

The Senior CMC Project Manager, reporting to the Executive Director, Head of Program Management, will lead CDMO coordination and program integration for Aurion’s late-stage cell therapy program. This individual will manage external manufacturing partners ensuring timelines, deliverables, and risks are aligned and visible across the full program. If you are a highly motivated and experienced CMC project management professional passionate about developing innovative cell therapies, we encourage you to apply for this exciting opportunity to join our team.

• Drive strategic CDMO partnerships, serving as the primary day-to-day project manager and liaison to external partners ensuring alignment of project plans, timelines, and priorities.
• Oversee CDMO performance and execution, monitoring progress against SOWs, timelines, and quality agreements, and coordinating timely resolution of deviations, delays, or scope changes.
• Manage financial processes including PO creation, invoice review, and budget tracking to ensure on-time, on-budget delivery.
• Lead internal and joint governance meetings, including scheduling, agenda preparation, and follow-up of decisions, risks, and actions. Consolidate CDMO and CMC program updates for dashboards and leadership reporting.
• Build and maintain strong cross-functional relationships, fostering collaboration between Aurion, CDMO and internal SME’s ensuring clear communication and accountability across functions.
• Own CMC project documentation and tools, maintaining integrated timelines, risk registers, decision logs, and action trackers, and ensuring Smartsheet and SharePoint systems are current and standardized
• Align cross-functional teams across Process Development, Manufacturing, Quality, Regulatory, and Supply Chain to ensure integrated planning, clear ownership, and consistent execution of program deliverables

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.

We want our people to wake up every morning excited and energized for work. We value employees, which is…