Associate Director, Manufacturing Business Operations – Strategy

🔥 0 minutes ago

🐎 Kentucky, New Hampshire, +10 more states – Remote

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

💵 $203k - $228k / year

⏰ Full Time

🟠 Senior

⚙️ Business Operations

🦅 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

• Provide strategic, technical, operational, and business leadership across the Manufacturing organization • Serve as the strategic and operational integrator for Manufacturing • Partner across External Manufacturing, MSAT, Supply Chain, Quality, Regulatory, Finance, Legal, and external manufacturing partners • Develop manufacturing strategies and scenarios for how, where, when, and with what resources manufacturing activities are executed • Own the Manufacturing team book of work, detailed timelines/smartsheets, integrating technical milestones, dependencies, budgets, and external commitments • Drive portfolio prioritization and execution • Lead Manufacturing SOW, contract, budget, PO, and invoice management • Translate technical strategies into clear scopes, deliverables, schedules, financial commitments, and business arrangements • Support Manufacturing leadership and technical leads to develop integrated late-stage, commercialization, commercial manufacturing, and operational project timelines and dependencies at site • Develop risk-based manufacturing scenarios and contingency plans • Lead commercialization and manufacturing network planning across sites, including capacity, sourcing, redundancy, business continuity, cross-site integration, CDMO strategy, and major lifecycle transitions • Support the company as it advances through late-stage development, BLA submission, commercialization, commercial launch, and lifecycle management

🎯 Requirements

• B.S., M.S., or Ph.D. in a scientific or engineering discipline • Preferred 8-10 years of experience in MSAT, Manufacturing, or PD for biologics/cell therapies • Significant experience in Manufacturing, MSAT, External Manufacturing, Technical Operations, Process Development, Manufacturing Strategy, or a related technical operations function • Experience in late-stage / commercial cell and gene therapy required • Experience with multiple commercial cell therapy products, a plus • Proven track record of managing books of work, contracts, and technical strategies in support of late-stage or commercial GMP manufacturing • Experience supporting CMC sections of regulatory submissions and informational requests • Experience with manufacturing network planning, site selection, capacity planning, business continuity, second sourcing, or cross-site manufacturing integration preferred • 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 • Strong knowledge of technology transfer, commercial GMP manufacturing, validation/PPQ, comparability, investigations, process performance, and commercial lifecycle management • Strong combination of technical manufacturing expertise, strategic thinking, business acumen, commercial operations, and program leadership • Ability to translate complex technical strategies into executable plans, SOWs/contracts, budgets, schedules, and operating models • Demonstrated ability to drive complex initiatives to completion and develop creative, practical, risk-based solutions in fast-paced, resource-constrained environments • Strong leadership and communication skills with the ability to influence across functions, external partners, and executive stakeholders • Excellent technical writing and document review skills • Proficiency with Microsoft Office and project/portfolio management tools • Financial planning, ERP/procurement, and data visualization experience preferred • Ability to travel up to 25%

🏖️ Benefits

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