Senior Process Engineer/ Scientist

Location: Madison, WI (onsite)

Company Overview

Fujifilm Cellular Dynamics (FCDI) is a Contract Development and Manufacturing Organization (CDMO) focused on iPSC‑derived cell therapy products. The company leverages induced pluripotent stem cell (iPSC) technology to advance drug discovery, disease modeling, cell therapy manufacturing, and research tools. Headquartered in Madison, Wisconsin, with global operations based in Tokyo, Fujifilm employs over 70,000 people across healthcare, electronics, business innovation, and imaging.

About the Role

The Senior Process Engineer will serve as a technical authority within the Process Development (PD) team, leading late‑stage clinical and commercial process development activities for iPSC‑derived cell therapy products. This hands‑on laboratory position involves building best practices, technical frameworks, and fit‑for‑purpose approaches for process characterization, scale‑up studies, process control strategy development, and process lifecycle planning. The engineer will collaborate closely with PD leadership, cross‑functional teams, and CDMO clients to ensure scientifically sound, robust, and regulatory‑compliant processes that meet project commitments.

Responsibilities

• 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, 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 (ICH, FDA, GMP, industry guidance) to ensure 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, risk‑based decisions and recommendations based on complex or incomplete data, clearly communicating technical risk, trade‑offs, 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 audiences through technical presentations, written reports, and project summaries.
• Collaborate with cross‑functional teams and 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 experimental design, process evaluation, data analysis, troubleshooting, and documentation; and lead small‑ to mid‑sized process development projects as assigned.
• Identify and develop innovative, potentially patentable process improvements, technologies, or approaches in support of the organization’s research, development, and commercial objectives.
• Perform other duties as assigned.

Required Qualifications

• PhD in a biosciences or bioengineering discipline (or related field) with at least 2 years of experience, or a Master’s degree with at least 5 years of experience, or a Bachelor’s degree with at least 7 years of experience; relevant industry experience strongly preferred.
• Demonstrated experience leading late‑stage clinical and commercial process development for biopharmaceutical manufacturing, including process characterization, robustness, scale‑up, and definition of manufacturing operation ranges.
• Experience with scalable upstream and/or downstream unit operations used in cell manufacturing (e.g., multi‑layer culture vessels, bioreactors, media platforms, automated cell washing/concentration, fill/finish).
• Strong understanding of Quality by Design, process validation, and GMP manufacturing requirements; experience translating development knowledge into technology transfer, PPQ, control strategy, and commercial manufacturing plans.
• Proven ability to partner with MSAT, Manufacturing, Quality, Analytical Development, and other cross‑functional teams to advance processes from development through technology transfer and GMP manufacturing.
• Ability to develop and defend technical strategies using scientific and engineering principles, including interpretation of complex data and application of statistical/design‑of‑experiments approaches.
• Excellent written and verbal communication skills for conveying technical strategies, risks, and recommendations to diverse technical and business stakeholders.
• Demonstrated mentorship experience, fostering the growth of engineers and scientists and advancing process development practices.
• Strong problem‑solving and organizational skills; ability to manage multiple technical projects independently, reprioritize as needs evolve, and maintain alignment with stakeholders, quality standards, and project commitments.
• Willingness to provide flexible support for time‑sensitive activities outside standard business hours, including evenings, weekends, and holidays.
• Ability to maintain a regular laboratory presence and provide hands‑on experimental support as required.
• Physical ability to occasionally lift up to 50 pounds and work safely with hazardous materials (chemicals, electrical equipment, human tissue) while wearing standard laboratory PPE.

Preferred Qualifications

• Experience developing manufacturing processes for cell‑based products; prior work with iPSC‑derived cell types is a plus.
• Familiarity with analytical methods for assessing cell growth and differentiation (cell counting, metabolite analysis, flow cytometry, PCR, microscopic imaging).
• Experience working within a regulated environment with a strong understanding of expectations and best practices.
• Background in a contract development and manufacturing organization (CDMO) setting.