Associate Director, Manufacturing Business Operations – Strategy

Aurion Biotech

. Provide strategic, technical, operational, and business leadership across the Manufacturing organization .

Posted 10/2/2026full-timeRemote • United StatesSenior💰 $203,000 - $228,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Manufacturing Strategy, Technical Operations, and Commercialization for cell and gene therapies, with a strong focus on regulatory compliance and project management. Proven ability to lead cross-functional teams and develop integrated manufacturing plans that align with business objectives.

Highest-signal resume keywords

Manufacturing StrategyTechnical OperationsRegulatory SubmissionsProject ManagementGMP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Manufacturing StrategyTechnical OperationsProcess DevelopmentGMP ManufacturingTechnology TransferCommercial Lifecycle ManagementRisk-Based SolutionsCapacity PlanningFinancial PlanningData Visualization

Soft Skills

LeadershipCommunicationStrategic ThinkingInfluencing SkillsProblem Solving

Tools & Technologies

Microsoft OfficeProject Management ToolsERP SystemsPortfolio Management Tools

Industry Keywords

Cell TherapyGene TherapyBiologicsGMPsICH GuidelinesCommercial ManufacturingExternal ManufacturingLate-Stage DevelopmentBLA SubmissionCross-Site Integration

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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