Associate Director, Manufacturing Business Operations & Strategy

Aurion Biotech Inc. | Fully Remote (WA or MA preferred; IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, or WA)

Salary Range: $203,000 to $228,000

About the Position

Aurion Biotech is seeking an Associate Director, Manufacturing Business Operations & Strategy to provide strategic, technical, operational, and business leadership across the Manufacturing organization as Aurion advances through late-stage development, BLA submission, commercialization, commercial launch, and lifecycle management.

Serving as Head of Manufacturing Business Operations & Strategy, this person will serve as the strategic and operational integrator for Manufacturing, partnering across External Manufacturing, MSAT, Supply Chain, Quality, Regulatory, Finance, Legal, and external manufacturing partners. The successful candidate will combine technical understanding of biologics or cell therapy manufacturing with commercial operations experience, strategic thinking, and business acumen. This individual will develop creative manufacturing strategies and scenarios for how, where, when, and with what resources manufacturing activities are executed to achieve technical, regulatory, supply, and business objectives.

Key Responsibilities

• •Own the Manufacturing team book of work, detailed timelines and smartsheets, integrating technical milestones, dependencies, budgets, and external commitments to drive portfolio prioritization and execution.
• •Lead Manufacturing SOW, contract, budget, PO, and invoice management, translating technical strategies into clear scopes, deliverables, schedules, financial commitments, and business arrangements.
• •Support Manufacturing leadership (ExM and MSAT) and technical leads to develop integrated late-stage, commercialization, commercial manufacturing, and operational project timelines and dependencies at site.
• •Develop creative, risk-based manufacturing scenarios and contingency plans that optimize activities, resources, investments, and network capabilities while protecting supply and preserving future optionality.
• •Lead commercialization and manufacturing network planning across sites, including capacity, sourcing, redundancy, business continuity, cross-site integration, CDMO strategy, and major lifecycle transitions.
• •Other duties as assigned.

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 treats corneal edema secondary to endothelial dysfunction and is one of the first clinically validated cell therapies for corneal care, 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 and is preparing for clinical trials in the U.S. The company is privately held and backed by Alcon, the global leader in eye care.

Core values include Stewardship, Transformation, and Grit.

Benefits and Perks

• •Full health insurance for employees and their families
• •401(k) matching, EAP, FSA, and generous PTO
• •Competitive compensation packages
• •Paid parking and subsidized commuter passes
• •In-office catered lunches, team events, and community projects

Qualifications and Education

• •B.S., M.S., or Ph.D. in a scientific or engineering discipline
• •Preferred 8-10 years of experience in MSAT, Manufacturing, or Process Development for biologics or cell therapies
• •Experience in late-stage and commercial cell and gene therapy required; experience with multiple commercial cell therapy products is 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

Required Skills and Abilities

• •Background in cell therapy, viral vector, or other complex biologic modalities highly preferred
• •Strong knowledge of technology transfer, commercial GMP manufacturing, validation and 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 and portfolio management tools; financial planning, ERP and procurement, and data visualization experience preferred
• •Ability to travel up to 25%