CMC Project Manager

JOB TITLE: CMC Project Manager

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: $111,000 to $136,000. The midpoint of the range is $125,000. The ideal candidate would be hired at or around the midpoint.

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.

We are seeking a CMC project manager, reporting to the Associate Director, Technical Product Leadership, to support our CDMO and clinical trial activities. 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

• CDMO Oversight: Manage CDMO performance, ensuring adherence to service and quality agreements, execution of SOWs and organizing performance discussions 
• Timeline Management: Develop and maintain project timelines, ensuring all milestones are met according to project requirements.
• Meeting Coordination: Schedule and facilitate project meetings, including setting agendas, preparing materials, taking accurate meeting minutes, and distributing them to relevant stakeholders.
• Communication: Serve as the primary point of contact for project-related communication between internal teams, external vendors, and stakeholders.
• Finance Management: Responsible for developing and managing budgets, as well as reviewing and approving vendor invoices to ensure financial accuracy and compliance with organizational policies.
• Risk Management: Identify and mitigate project risks, escalating issues as necessary to ensure timely resolution.
• Document Management: Maintain accurate and up-to-date project documentation, including project plans, status reports, and other relevant materials.
• Performs 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.

• Bachelor's degree in a related field (e.g., Project Management, Engineering, Life Sciences) or equivalent experience
• 5+ years of experience in a pharmaceutical or biotechnology setting with 3+ years of CMC project management
• 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
• PMP certification or equivalent is a plus

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