Senior Director, Manufacturing & Supply Chain

Geron Corporation•Parsippany-Troy Hills, NJ

10h•$235,000 - $265,000•Hybrid

About The Position

The Senior Director of Manufacturing and Supply Chain provides strategic and operational leadership for end-to-end manufacturing and supply chain activities across the product lifecycle. This role is accountable for external manufacturing, technology transfer, clinical and commercial supply, demand and supply planning, inventory management, packaging and labeling, distribution, and continuity of supply. The Senior Director develops and executes phase-appropriate strategies that enable compliant, reliable, and cost-effective supply for clinical studies, regulatory approval, launch, and ongoing commercialization. The position will be required to attend occasional in person meetings in the Parsippany, NJ office with a strong preference to be located on the East Coast.

Requirements

Ph.D. or Master’s degree in chemical engineering, pharmaceutical sciences, chemistry, or a related discipline; advanced degree preferred
12+ years of progressive pharmaceutical or biotechnology experience in manufacturing and supply chain, including leadership responsibility for late-stage clinical and commercial programs
Demonstrated experience managing CMOs/CDMOs, contract testing laboratories, suppliers, packaging vendors, and logistics partner
Proven experience in clinical and commercial supply planning, forecasting, production planning, inventory management, packaging and labeling, distribution, and supply-risk mitigation
Experience transitioning products from late-stage development through process validation, regulatory approval, commercial launch, and lifecycle management
Experience supporting CMC content for global regulatory submissions, agency interactions, inspections, product registration, and post-approval commitments

Nice To Haves

Experience with oligonucleotide or other complex-molecule manufacturing is preferred

Responsibilities

Lead the integrated manufacturing and supply chain strategy across clinical development, registration, launch, and commercial lifecycle management
Provide end-to-end oversight of drug substance and drug product manufacturing, scale-up, technology transfer, process characterization, validation, and ongoing process performance
Direct and govern contract manufacturers, testing laboratories, raw material suppliers, packaging and labeling vendors, logistics providers, and other external partners; establish expectations and resolve technical, quality, delivery, capacity, and cost issues
Lead clinical and commercial supply planning and execution, including forecasting, production planning, capacity management, packaging and labeling, inventory strategy, distribution, and launch readiness
Develop supply-continuity and risk-mitigation strategies, including safety-stock targets, dual sourcing, critical-material monitoring, business continuity, and scenario planning
Ensure manufacturing and supply operations comply with cGMP requirements, approved regulatory filings, quality agreements, and Company procedures; partner with Quality on deviations, CAPAs, change controls, and inspection readiness
Establish KPIs and governance forums, analyze operational performance and trends, and drive corrective actions and continuous improvement
Prepare and manage operating budgets, contracts, project plans, timelines, and resource forecasts for manufacturing and supply chain activities
Collaborate with Quality, Regulatory Affairs, Clinical Operations, Commercial, Finance & Accounting, Program Management, and other functions to align deliverables with corporate and program objectives
Identify and communicate technical, operational, regulatory, and supply risks; recommend alternatives and escalate issues with clear impact assessments and mitigation plans
Lead, develop, and mentor a high-performing team; including workforce planning, hiring, goal setting, coaching, performance management, succession planning, and building organizational capability aligned with business needs