About this opportunity
Geron Corporation lists this Senior Director, Manufacturing & Supply Chain opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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Senior Director, Manufacturing & Supply Chain
Regular Full-Time Director New Jersey, Parsippany, NJ, US
6 days ago Requisition ID: 1314
Salary Range: $235,000.00 To $265,000.00 Annually
Position Summary
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.
The Senior Director will report to the Senior Vice President, Chief Technical Officer.
Primary 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 elevate 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
Enterprise-level strategic thinking with the ability to translate business objectives into practical manufacturing and supply plans
Extensive knowledge of cGMP, pharmaceutical quality systems, global regulatory expectations, and clinical and commercial supply operations
Demonstrated success leading external manufacturing networks and complex cross-functional programs in a virtual or outsourced operating model
Strong business and financial acumen, including budgeting, contract negotiation, capacity planning, cost management, and inventory optimization
Proven ability to identify risk early, make sound decisions amid ambiguity, and communicate clear recommendations to senior leadership
Excellent leadership, talent development, collaboration, influencing, negotiation, and written and verbal communication skills
Experience
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
Experience with oligonucleotide or other complex-molecule manufacturing is preferred
EEO Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron’s intention to comply with all applicable federal, state, and local laws that apply to the Company’s employees.
Salary Statement
Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background.
General Salary Range
$235,000 to $265,000
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.