Position OverviewFCDI 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.
Job DescriptionEssential 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 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 other closely related field plus at least two (2) years of related experience; or a Master's degree in a comparable field plus at least five (5) years of relevant experience; or a Bachelor's degree in a comparable field plus at least seven (7) years of related experience; relevant industry experience strongly preferred
- Demonstrated experience leading late-stage clinical and commercial process development activities for biopharmaceutical manufacturing processes, including process characterization, process robustness, scale-up, and definition of manufacturing operation ranges
- Experience with scalable upstream and/or downstream unit operations commonly used in cell manufacturing (e.g., multi-layer culture vessels, bioreactors, media manufacturing platforms, automated cell washing and concentration, fill/finish)
- Strong understanding of Quality by Design, process validation, and GMP manufacturing requirements, with experience translating process development knowledge into strategies that support technology transfer, PPQ, control strategy, and commercial manufacturing
- Experience partnering with MSAT, Manufacturing, Quality, Analytical Development, and other cross-functional teams to advance processes from development through technology transfer and GMP manufacturing
- Demonstrated ability to develop and defend technical strategies using scientific and engineering principles, including interpretation of complex process data and application of statistical/design of experiments approaches
- Strong written and verbal communication skills, with the ability to effectively communicate technical strategies, process understanding, risks, and recommendations to a range of technical and business stakeholders (both internal and external)
- Demonstrated ability to mentor and develop other engineers and scientists and contribute to the advancement of process development practices and technical capabilities within the organization
- Strong problem-solving and organizational skills, with demonstrated ability to manage multiple technical projects independently, reassess priorities as needs evolve, and adjust plans in a timely, disciplined manner while maintaining alignment with stakeholders, quality standards, and project commitments
- Ability to provide flexible support for time-sensitive process development activities outside of standard business hours, including evenings, weekends, and holidays, as needed
- Ability to maintain a regular laboratory presence and provide active, hands-on support for experimental execution, as required by project needs
- Ability to occasionally lift up to 50 pounds
- Ability to work with hazardous materials (i.e., chemicals, electrical equipment, and human tissue) without endangering oneself or others
- Ability to wear standard laboratory PPE
Preferred Qualifications- Experience developing manufacturing processes for cell-based products; previous experience with iPSC-derived cell types is a plus.
- Experience with and understanding of a variety of common analytical methods used to assess cell growth and differentiation, including cell counting, metabolite analysis, flow cytometry, PCR, and microscopic imaging
- Experience working within a regulated environment, with a strong understanding of expectations and best practices
- Experience working with or within a contract development and manufacturing organization (CDMO)
