Director, Manufacturing Validation & Comparability

Apply Description JOB TITLE: Director, Manufacturing Validation & Comparability LOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS or WA. SALARY RANGE: $225,000 to $250,000 ABOUT THE POSITION Reporting to the Executive Director of Manufacturing, the Director, Head of Manufacturing Validation and Comparability is responsible for leading the strategy, execution, and management of validation and comparability activities at Aurion, ensuring readiness for BLA and other Regulatory submissions. The Head of Manufacturing Validation and Comparability will lead a team of engineers that is accountable to author and own source documents (risk assessments, protocols, reports) for global regulatory submissions and is responsible to form, lead, and motivate cross-functional teams and CDMO partners to deliver these goals. Your peers will be the Heads of MSAT and External Manufacturing. If you are a highly motivated and experienced GMP manufacturing validation professional with a passion for developing innovative cell therapies, we encourage you to apply for this exciting opportunity to join our team. KEY RESPONSIBILITIES Drive cross-functional alignment with internal and external CDMO stakeholders for comparability and validation activities (Quality, Process Sciences (PS), Process Development (PD), Analytical Development (AD), MSAT, External Manufacturing, etc.). Ensure comparability and validation strategies for Drug Substance and Drug Product are compliant with Regulatory expectations. Identify and communicate to the broader cross-functional team any risks and mitigations for comparability and validation activities. Contribute to Regulatory meeting strategy and authoring (e.g., briefing books, etc.). Provide strategy, author, and review Module 3 section content of regulatory submissions. Directly manage and mentor a team of high-performing engineers, encouraging project ownership and fostering technical and career development. Lead and provide technical oversight and guidance to the Manufacturing Validation team, responsible for Drug Substance and Drug Product comparability and validation activities including: Leading and owning comparability strategies, risk assessments, and protocols for critical late-stage activities (site to site transfers, process changes pre-PPQ), as well as comparability reports and source documents for Regulatory submissions. Creating and managing Process Validation Master Plan (PVMP). Development of validation strategies at all CDMOs including process performance qualification (PPQ) and ancillary process validation studies. Creating and managing documents leading to validation (range justification report, process control strategy, process validation protocols, PPQ protocols). Leading and managing product-specific validation studies under protocol with QMS documentation for Regulatory submissions. Developing and reviewing CDMO site-specific validation studies to ensure alignment with the overall validation strategy. Foster a culture of data-driven decision making, continuous improvement, and compliance across internal teams and CDMOs. Perform other duties as assigned to meet program and company objectives. 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 12+ years of experience in MSAT, Process Development, and/or External Manufacturing; with at least 5+ years in direct people management leading cross-functional teams or direct reports. Process Validation and/or Comparability for biologics/cell therapies highly preferred. Experience in late-stage or commercial cell and gene therapy required. Experience with multiple commercial cell therapy products, a plus. Proven track record of successful design and execution of comparability studies, PPQ, and other validation activities in support of late-stage or commercial GMP manufacturing. Experience authoring and defending CMC sections of regulatory submissions and regulatory inspections. Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies. REQUIRED SKILLS AND ABILITIES Background in cell therapy, viral vector, or other complex biologic modalities highly preferred. Proven experience in people management and leadership in MSAT, Process Development, and/or External Manufacturing. Working knowledge of ICH guidelines (e.g., Q5E, Q8, Q9, Q10, Q12) and FDA Process Validation guidance. Proficiency in risk-management methodologies (FMEA, HACCP) and statistical process control. Demonstrated experience authoring or reviewing risk assessments, protocols, and reports that feed directly into regulatory submissions (IND, BLA, MAA, etc.). Demonstrated track record of driving projects to completion in a fast-paced, evolving environment. Strong understanding of cGMP regulations and requirements for creating process control strategies and manufacturing of cell therapies. Excellent leadership, communication, and interpersonal skills—capable of influencing at all organizational levels and with external partners. Able to manage multiple priorities. Strong technical writing and document review capabilities. Strong analytical and problem-solving skills, with the ability to apply scientific and engineering principles to complex technical problems and data trending. Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment. Passion for building, managing, and mentoring high performing teams, fostering a culture aligned with Aurion Biotech values. Experience with MS Office products, JMP or other data analysis software. Ability to travel up to 25%. Salary Description $225,000 to $250,000