Senior Process Engineer

Senior Process Engineer

FCDI is recruiting for a Senior Process Engineer to support continued growth and ongoing customer projects within the Process Development (PD) team located in Madison, WI. As a Contract Development and Manufacturing Organization (CDMO), FCDI's PD team supports multiple customer programs by onboarding, developing, and transferring robust manufacturing processes for a diverse portfolio of iPSC-derived cell therapy products.

We are seeking an experienced, self-motivated, and detail-oriented process development engineer to serve as a technical authority within the PD team for late-stage clinical and commercial process development activities. In this hands-on laboratory role, you will continue building best practices, technical frameworks, and fit-for-purpose approaches for process characterization, scale-up studies, process control strategy development, and process lifecycle planning. You will collaborate closely with PD leadership and other cross-functional teams to ensure that processes and supporting strategies are scientifically sound, robust, phase-appropriate, and aligned with client needs and regulatory expectations.

The successful candidate will be motivated by the opportunity to partner closely with CDMO clients to plan, execute, and deliver high-quality process development work that meets project commitments and advances life-changing iPSC-derived therapies toward patient administration safely, efficiently, and with the highest standards of quality. This is an onsite role located at our sites in the Madison, WI area.

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."

Essential Job Functions

• Independently conceive, plan, and lead process development activities for multiple internal and external programs, applying advanced engineering and scientific judgment to develop robust, scalable, and commercially relevant processes.
• Evaluate and implement technologies that improve process understanding, robustness, scalability, automation, closure, and GMP readiness for cell manufacturing processes.
• Provide technical leadership and subject-matter expertise for late-stage clinical process development activities, including process characterization, scale-up and scale-down studies, design space development, process control strategy development, and process lifecycle planning.
• Apply expert knowledge of relevant regulatory, quality, and engineering requirements, including applicable ICH, FDA, GMP, and industry guidance, to ensure process development activities are scientifically sound, phase-appropriate, and aligned with regulatory expectations.
• Analyze and interpret complex process and experimental data, troubleshoot technical challenges, identify root causes, and recommend improvements to processes, equipment, experimental approaches, and development strategies.
• Make technically sound and scientific risk-based decisions and recommendations based on complex or incomplete sets of data, clearly communicating technical risk, tradeoffs, and recommendations to internal and external stakeholders.
• Develop and maintain accurate, complete, and compliant technical documentation, including development plans, study protocols and reports, process characterization documents, risk assessments, process descriptions, control strategy summaries, technical reports, and other project-related records.
• Communicate process development strategies, technical findings, and project status to cross-functional teams, clients, and diverse internal and external audiences through technical presentations, written reports, and project summaries.
• Collaborate with cross-functional teams and with clients to ensure process development activities support project timelines, product quality, regulatory requirements, technology transfer needs, and commercial objectives.
• Provide technical leadership, training, and mentorship to junior and mid-level engineers and scientists; promote consistency in…