Associate Director, Program Design CDMO
Full-time
FUJIFILM Biotechnologies
Position Overview FUJIFILM Cellular Dynamics, Inc. is seeking an Associate Director, Program Design to lead the scoping, design, and proposal development process for new CDMO business opportunities, from client request for proposal through contract signature. This individual contributor role serves as a key bridge between 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. The role reports to the Director of Strategic and CDMO Marketing and is expected to bring strong technical, operational, and commercial judgment to support high-quality proposals, clear client communication, and efficient transition of awarded work into Program Management. Collaborates closely with the centralized Program Management group and serves as the local representative. This is an on-site position in Madison, Wisconsin. Company Overview At FUJIFILM Cellular Dynamics, we're unlocking the power of human cells to change lives. Using revolutionary induced pluripotent stem cell (iPSC) technology, we drive advancements in drug discovery, disease modeling, cell therapy, research tools, and cell therapy manufacturing. Our mission is deeply meaningful, and we're looking for bold innovators to join us. At FUJIFILM Cellular Dynamics, you'll thrive in a collaborative and cutting-edge environment that encourages creativity and celebrates breakthroughs. If you're ready to do work that makes a real impact and propels healthcare forward, this is your chance to be part of something extraordinary for science, patients, and yourself. Our headquarters is in Madison, Wisconsin, a dynamic city celebrated for its lakes, parks, cultural richness, biotech leadership, and access to world-class academia. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Job Description Essential Job Functions
- Improve and sustain a harmonized process for authoring, managing, and delivering CDMO program proposals that support new business acquisition, in line with the central Program Design group.
- 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.
- Together with Program Management, assess site capacity, suite utilization, scheduling constraints, and operational readiness to inform proposal assumptions and support executable program designs.
- Together with finance and Program Management, develop proposed program pricing using approved cost allocation and pricing models, and secure appropriate approvals.
- Coordinate with Commercial, Site Leadership, Legal, and other stakeholders to deliver accurate, timely, and commercially competitive proposals to prospective clients.
- Review, upgrade and maintain proposal infrastructure in alignment with the central Program Design group, including databases for site services, labor assumptions, functional inputs, RFPs, proposal responses, assumptions, and related proposal history.
- 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.
- Ensure clear and timely communication across teams as needed, including planning discussions, progress updates, issue escalation, proposal reviews, closure, and lessons learned.
- 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.
- Maintain current knowledge of cell therapy industry standards, CDMO operating models, cGMP operations, corporate policies, and relevant best practices.
- 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.
- Contribute to a culture of safety, quality, accountability, and patient focus by complying with company procedures, policies, and applicable cGMP cell culture manufacturing requirements.
- Perform other duties as assigned based on business needs.
- 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.
- Ability to work independently, take ownership of complex assignments, and proactively engage cross-functional stakeholders to obtain required inputs and alignment.
- 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.
- Ability to synthesize and present complex technical, operational, and financial information clearly and concisely for internal stakeholders and external clients.
- Exceptional collaboration, communication, facilitation, project management, and organizational skills.
- Ability to operate effectively in a fast-paced, dynamic environment while managing multiple competing priorities and driving deliverables to completion.
- Demonstrated ability to develop, communicate, and execute project or proposal plans with clear ownership, timelines, milestones, and decision points.
- Experience supporting multiple simultaneous projects, proposals, or client opportunities with changing priorities and time-sensitive deliverables.
- Ability to lead through influence, interact effectively across functions and levels, resolve conflicts, and drive decisions among cross-functional teams.
- Continuous improvement mindset, with a commitment to standardization, innovation, operational discipline, and practical problem solving in an evolving CDMO environment.
Vacancy posted 21 days ago
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