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
ABOUT THE POSITION
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.
KEY RESPONSIBILITIES
- 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
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.
- Bachelor's degree in a related field (e.g., Project Management, Engineering, Life Sciences)
- 8+ years of experience in Biotech/Pharma setting with 5+ years CMC or external manufacturing project management
- Background in biotechnology or pharmaceutical development, with direct exposure to late-stage cell or gene therapy programs, preferred
- Strong organizational and time management skills, with the ability to prioritize tasks effectively
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Proficiency in Microsoft Office Suite, SharePoint, and Smartsheet
- Knowledge of regulatory requirements related to pharmaceutical or biotechnology projects is preferred
REQUIRED SKILLS AND ABILITIES
- Able to and comfortable with travel up to 25%
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
- Must have strong attention to detail and demonstrated decision making ability
- Ability to work individually and in a team environment
- Demonstrated excellence in written and verbal communication skills
- Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships
