CMC Project Manager

This a FullRemote job, the offer is available from: United States, Indiana (USA), Kentucky (USA), Massachusetts (USA), New Hampshire (USA), New Jersey (USA), New Mexico (USA), New York (USA), North Carolina (USA), Oregon (USA), Pennsylvania (USA), South Carolina (USA), South Dakota (USA), Texas (USA), Washington (USA)DescriptionJOB TITLE: CMC Project ManagerLOCATION:Remote - 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: $111,000 to $136,000ABOUT THE POSITIONAurion 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 MedicineAdvanced 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 Executive Director, Head of Program Management, 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. KEY RESPONSIBILITIES• Serve as the day-to-day liaison between internal teams and CDMO partner, coordinating project timelines, deliverables, and communications• Manage CDMO performance, ensuring adherence to service and quality agreements and effective execution of SOWs• Develop and maintain project timelines, ensuring all milestones are met according to project requirements.• Schedule and facilitate project meetings, including setting agendas, preparing materials, taking accurate meeting minutes, and distributing them to relevant stakeholders. • Serve as the primary point of contact for project-related communication between internal teams, external vendors, and stakeholders. • Support financial tracking for CDMO projects, including creation and management of SOWs, purchase orders, and change orders to ensure alignment with project scope and timelines• Identify project risks and escalating issues as necessary to ensure timely resolution.• Maintain accurate and up-to-date project documentation, including project plans, status reports, and other relevant materials. ABOUT AURION BIOTECHWith 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.comLIFE AT AURION BIOTECHWe 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:• RobustBenefits: 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.RequirementsQUALIFICATIONS AND EDUCATIONTo 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 or external manufacturing project management, direct exposure to 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 preferredREQUIRED 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 relationshipsSalary Description$111,000 to $136,000This offer from "Aurion Biotech" has been enriched by Jobgether.com and got a 75% flex score.Apply tot his job