Backed by 500 Global.
About the role
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.
What they're looking for
- 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 mentor and develop other engineers and scientists and contribute to the advancement of process development practices and technical capabilities within the organization
- 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
More about this role
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...
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