Senior Director, CMC and Manufacturing

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Senior Director, CMC and Manufacturing

Regular Full-Time Director New Jersey, Parsippany, NJ, US

28 days ago Requisition ID: 1314

Salary Range: $235,000.00 To $265,000.00 Annually

Position Summary

The Senior Director of CMC and Manufacturing provides strategic and operational leadership for commercial CMC, external manufacturing, and supply continuity. The Senior Director is accountable for reliable commercial production, process performance, control strategy, validation, regulatory CMC writing and compliance, post-approval changes, lifecycle management, and cost and capacity optimization. The Senior Director ensures robust, compliant, and sustainable manufacturing and supply capabilities that support global launch readiness, market demand, and ongoing commercialization. This 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 commercial CMC and manufacturing strategy across launch, market expansion, and product lifecycle management
• Provide technical oversight of drug substance and drug product manufacturing, specifications, control strategies, process validation, and continued process verification
• Ensure commercial manufacturing readiness and operational performance, including process robustness, right-first-time execution, yield, cycle time, capacity, reliability, and cost of goods
• Lead commercial technology transfers, site changes, scale-up, process improvements, comparability assessments, validation, and implementation of post-approval manufacturing changes
• Direct and govern CDMOs, CMOs, and critical material suppliers; establish technical and business expectations and resolve process, analytical, quality, capacity, delivery, and cost issues
• Own CMC strategy and content for commercial regulatory submissions, health authority responses, inspections, post-approval changes, annual reporting, commitments, and market maintenance activities
• Partner with Quality on deviations, investigations, CAPAs, change controls, product quality reviews, validation, data integrity, quality agreements, complaint trends, and inspection readiness
• Establish commercial manufacturing governance and KPIs; monitor process capability, analytical trends, supplier performance, cost, service, and quality, and drive corrective actions and continuous improvement
• Provide oversight of demand and supply planning, inventory strategy, and production scheduling to maintain reliable commercial supply while balancing customer service, cost, and working capital
• Partner with internal teams and external providers to manage supply continuity, logistics, and distribution risks, including mitigation plans for constrained materials, capacity, and market requirements
• Prepare and manage commercial CMC and manufacturing budgets, contracts, operating plans, capacity and resource forecasts, and external partner performance
• Identify and communicate commercial manufacturing, quality, regulatory, and supply risks; recommend alternatives and elevate issues with clear business impact assessments and mitigation plans
• Enterprise-level strategic thinking with the ability to translate commercial objectives into practical CMC, manufacturing, and supply plans
• Extensive knowledge of commercial cGMP drug substance and drug product sterile manufacturing of oligonucleotides, process validation, continued process verification, pharmaceutical quality systems, and global CMC regulatory expectations
• Strong technical and business judgment, with the ability to integrate process, analytical, quality, regulatory, supply, capacity, service, and cost considerations
• Proven ability to identify commercial risks early, make sound decisions amid ambiguity, and communicate clear recommendations to senior leadership and health authorities
• 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, biochemistry, or a related discipline
• 12+ years of progressive pharmaceutical or biotechnology experience in CMC and manufacturing, including significant leadership responsibility for commercial products and operations
• Demonstrated experience with commercial drug substance and drug product manufacturing, analytical controls, specifications, process validation, continued process verification, technology transfer, and lifecycle management
• Demonstrated success leading commercial manufacturing, product lifecycle management, post-approval changes, regulatory filings, and external manufacturing networks in a virtual or outsourced operating model
• Proven experience authoring and reviewing commercial CMC submissions, responding to health authority questions, supporting agency interactions and inspections, and managing post-approval changes and commitments
• Demonstrated experience managing global CDMOs/CMOs, contract testing laboratories, and critical raw material suppliers, including technical governance, capacity planning, cost management, and performance oversight
• Experience leading launch readiness, process performance qualification, regulatory approval, commercial scale-up, market supply, and ongoing process and product performance monitoring
• Experience with oligonucleotide or other complex-molecule commercial 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