Associate Director, Manufacturing Business Operations – Strategy

This is a fully remote position, open to applicants in Kentucky, +11 more states.

📋 Description

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

• Act as the strategic and operational integrator for Manufacturing initiatives.

• Collaborate with External Manufacturing, MSAT, Supply Chain, Quality, Regulatory, Finance, Legal, and external manufacturing partners.

• Formulate manufacturing strategies and scenarios to determine how, where, when, and with what resources manufacturing activities are carried out.

• Manage the Manufacturing team's portfolio of work, including detailed timelines and smartsheets, while integrating technical milestones, dependencies, budgets, and external commitments.

• Drive the prioritization and execution of the portfolio.

• Oversee Manufacturing SOW, contract, budget, PO, and invoice management.

• Convert technical strategies into clear scopes, deliverables, schedules, financial commitments, and business arrangements.

• Assist Manufacturing leadership and technical leads in creating integrated late-stage, commercialization, commercial manufacturing, and operational project timelines and dependencies at the site level.

• Develop risk-based manufacturing scenarios and contingency plans.

• Lead planning for commercialization and the manufacturing network across sites, focusing on capacity, sourcing, redundancy, business continuity, cross-site integration, CDMO strategy, and significant lifecycle transitions.

• Support the organization as it progresses through late-stage development, BLA submission, commercialization, commercial launch, and lifecycle management.

⛳️ Requirements

• Bachelor’s, Master’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.

• Extensive experience in Manufacturing, MSAT, External Manufacturing, Technical Operations, Process Development, Manufacturing Strategy, or a related technical operations function.

• Required experience in late-stage/commercial cell and gene therapy.

• Experience with multiple commercial cell therapy products is a plus.

• Proven history of managing portfolios, contracts, and technical strategies in support of late-stage or commercial GMP manufacturing.

• Experience supporting CMC sections of regulatory submissions and informational requests.

• Preferred experience in manufacturing network planning, site selection, capacity planning, business continuity, second sourcing, or cross-site manufacturing integration.

• Strong understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies.

• Background in cell therapy, viral vector, or other complex biologic modalities is highly preferred.

• In-depth knowledge of technology transfer, commercial GMP manufacturing, validation/PPQ, comparability, investigations, process performance, and commercial lifecycle management.

• A strong combination of technical manufacturing expertise, strategic thinking, business acumen, commercial operations, and program leadership is essential.

• Ability to translate intricate technical strategies into actionable plans, SOWs/contracts, budgets, schedules, and operational models.

• Demonstrated capability to drive complex initiatives to completion and devise innovative, practical, risk-based solutions in fast-paced, resource-constrained settings.

• 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 in Microsoft Office and project/portfolio management tools.

• Preferred experience in financial planning, ERP/procurement, and data visualization.

• Willingness to travel up to 25%.

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching program.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous Paid Time Off (PTO).

• Competitive compensation packages.

• Paid parking facilities.

• Subsidized commuter passes.

• In-office catered lunches.

• Team-building events.

• Opportunities for community projects.