Associate Director, Program Design CDMO

About the role

The Associate Director, Program Design at FUJIFILM Cellular Dynamics, Inc. will lead the scoping, design, and proposal development process for new CDMO business opportunities. This role bridges Commercial, Program Management, Site Leadership, Finance, Legal, R&D, Process and Analytical Development, Manufacturing, Supply Chain, Facilities, and Quality to translate client requirements into executable program scopes, assumptions, timelines, capacity plans, and pricing models.

Responsibilities

• Partner with the Commercial Sales Team to review customer requests for proposals, clarify client requirements and assumptions, participate in client discussions, deliver FCDI proposals, and respond to follow-up questions.
• Define program scope, including technical requirements, materials, equipment, timelines, resource needs, and key assumptions in collaboration with technical functions and designated subject matter experts.
• Assess site capacity, suite utilization, scheduling constraints, and operational readiness to inform proposal assumptions and support executable program designs.
• Develop, monitor, and report key performance indicators for proposal volume, turnaround time, win/loss drivers, proposal quality, and other metrics related to Program Design responsibilities.
• Drive timely decision-making by completing analyses, identifying risks, proposing mitigations, and communicating tradeoffs clearly to stakeholders.
• Translate approved proposals into initial Statements of Work once FCDI is selected, and ensure a structured handoff of scope, assumptions, commitments, and risks to Program Management.
• Evaluate the suitability of new technologies, equipment, scalability, and manufacturability considerations for prospective client programs in partnership with R&D, Process and Analytical Development, Manufacturing, Supply Chain, Facilities, and Quality.

Requirements

• Bachelor’s degree in a scientific, engineering, business, or related discipline plus a minimum of 7 years of relevant experience; or Master’s degree plus a minimum of 5 years of relevant experience; or Ph.D. plus a minimum of 2 years of relevant experience.
• Relevant experience includes experience in CDMO, biologics, gene therapy, or cell therapy industry, including technical and regulatory familiarity with development, technology transfer, manufacturing, cell culture, and drug product.
• Demonstrated understanding of process development, analytical development, manufacturing, quality, supply chain, and/or technical operations within a biologics, gene therapy, or cell therapy environment is required.
• Strong technical writing skills, with experience developing clear proposals, scopes, assumptions, project plans, and client-facing materials.
• Critical thinking and problem-solving skills, including the ability to analyze complex technical and business issues, evaluate alternatives, and recommend practical solutions.
• Financial and business acumen, including experience with cost assumptions, pricing inputs, proposal economics, and business case considerations.
• Exceptional collaboration, communication, facilitation, project management, and organizational skills.
• Experience supporting multiple simultaneous projects, proposals, or client opportunities with changing priorities and time-sensitive deliverables.

Qualifications

• Bachelor’s degree in a scientific, engineering, business, or related discipline plus a minimum of 7 years of relevant experience; or Master’s degree plus a minimum of 5 years of relevant experience; or Ph.D. plus a minimum of 2 years of relevant experience.
• Relevant experience includes experience in CDMO, biologics, gene therapy, or cell therapy industry, including technical and regulatory familiarity with development, technology transfer, manufacturing, cell culture, and drug product.
• Demonstrated understanding of process development, analytical development, manufacturing, quality, supply chain, and/or technical operations within a biologics, gene therapy, or cell therapy environment is required.
• Strong technical writing skills, with experience developing clear proposals, scopes, assumptions, project plans, and client-facing materials.
• Critical thinking and problem-solving skills, including the ability to analyze complex technical and business issues, evaluate alternatives, and recommend practical solutions.
• Financial and business acumen, including experience with cost assumptions, pricing inputs, proposal economics, and business case considerations.
• Exceptional collaboration, communication, facilitation, project management, and organizational skills.
• Experience supporting multiple simultaneous projects, proposals, or client opportunities with changing priorities and time-sensitive deliverables.