Aurion Biotech Inc.

Compensation

Full Description

Description: JOB TITLE: Director, CMC Technical Product Leadership LOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NH, NM, NY, PA, SC, SD, TX, KY, NJ or WA. REPORTS TO: Chief Manufacturing Officer SALARY RANGE: $220,000 to $242,000 ABOUT THE POSITION The Director, CMC Technical Product Leadership will report to the Chief Manufacturing Officer and will lead CMC technical resources to deliver CMC strategy and execution through approval, commercial launch, and lifecycle sustainability. The Director, CMC TPL will also be responsible for creating and managing the CMC risk register, as well as the CMC project plan. KEY RESPONSIBILITIES • Create and maintain CMC project plans to deliver on critical late phase or commercial CMC strategy and activities. • Work with the Quality Product Lead (QPL) to lead and drive the cross-functional CMC strategy for BLA-enabling milestones to ensure seamless transition to commercial manufacturing. • Develop and oversee mitigation projects from the CMC risk register in collaboration with stakeholders across Quality, Process Sciences, Process Development, Analytical Development, External Manufacturing, MSAT, and Regulatory Affairs. • Anticipate technical and operational challenges and provide clear, data-driven recommendations, including risks and tradeoffs, to senior leadership to enable timely and informed decision-making. • Prioritize and drive continuous improvements into the project plan across external network. • Collaborate with CMC PM to ensure programs are within budget and timeline and to provide regular updates. • Collaborate with key stakeholders (Process Sciences, Process Development, MSAT, Ext Manufacturing, Quality (QA, QC, PQL), and Analytical Development) to ensure investigations are complete, mitigation actions aligned, and a clear, integrated path forward is defined to support priority CMC needs. • Communicate overall health of CMC efforts, especially technical or operational risks, to support regulatory strategy. • Review Module 3 content to support regulatory filings (INDa, AR, CTAs, BLA, etc.). • Manage team of TPLs. 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 • 9+ 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. • Demonstrated success managing matrixed teams, CDMO partnerships and delivering clinical/commercial milestones. • Proven track record managing cross functional teams. • Experience authoring and defending CMC sections of regulatory submissions. • Solid understanding of cGMP regulations, ICH guidelines, and global regulatory expectations for biologics. REQUIRED SKILLS AND ABILITIES • Background in cell therapy, viral vector, or other complex biologic modalities highly preferred. • Strong analytical and problem-solving skills with a data-driven mindset. • 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., SmartSheets, JMP, Minitab). • Ability to thrive in a fast-paced, rapidly evolving environment and meet aggressive timelines.