Director, Manufacturing Validation – Comparability

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🐎 Kentucky, New Hampshire, +11 more states – Remote

🐎 Kentucky – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🎸 Mississippi – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $225k - $250k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Aurion Biotech

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2022

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 $120M Venture Round - Aurion Biotechnologies on 2022-04

Healthcare • Manufacturing • Biotechnology

Aurion Biotech is a clinical-stage company developing first-in-class regenerative cell therapies to restore vision by treating corneal endothelial disease and other causes of blindness. The company focuses on manufacturing-scale cell therapy platforms, using human donor corneal endothelial cells combined with supportive compounds (e. g. , rho-kinase inhibitor) to repopulate the corneal endothelium, reduce reliance on donor tissue, and enable less-invasive alternatives to graft-based keratoplasty. Aurion conducts global clinical trials, holds FDA Breakthrough Therapy and RMAT designations for its lead product AURN001, and aims to expand access to advanced ophthalmic care worldwide.

📋 Description

• Lead the strategy, execution, and management of manufacturing validation and comparability activities, ensuring readiness for BLA and other regulatory submissions • Lead a team of engineers accountable for authoring and owning source documents, including risk assessments, protocols, and reports, for global regulatory submissions • Form, lead, and motivate cross-functional teams and CDMO partners • Drive cross-functional alignment with Quality, Process Sciences, Process Development, Analytical Development, MSAT, External Manufacturing, and external CDMO stakeholders • Ensure Drug Substance and Drug Product comparability and validation strategies comply with regulatory expectations • Identify and communicate risks and mitigations for comparability and validation activities • Contribute to regulatory meeting strategy and authoring, including briefing books • Provide strategy, author, and review Module 3 regulatory submission content • Directly manage and mentor engineers, fostering project ownership and technical and career development • Provide technical oversight and guidance for Drug Substance and Drug Product comparability and validation activities • Lead comparability strategies, risk assessments, protocols, reports, and regulatory submission source documents for site-to-site transfers and pre-PPQ process changes • Create and manage the Process Validation Master Plan (PVMP) • Develop validation strategies at CDMOs, including PPQ and ancillary process validation studies • Create and manage validation documents, including range justification reports, process control strategies, process validation protocols, and PPQ protocols • Lead and manage product-specific validation studies under protocol with QMS documentation for regulatory submissions • Develop and review CDMO site-specific validation studies for alignment with the overall validation strategy • Foster data-driven decision making, continuous improvement, and compliance across internal teams and CDMOs • Perform other duties as assigned to meet program and company objectives

🎯 Requirements

• 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 • 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 is 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 • 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%

🏖️ Benefits

• Full health insurance for employees and their families • 401(k) matching • EAP • FSA • Generous PTO • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects