Senior Process Engineer, Cell Therapy Development

FUJIFILM; Madison (WI); Presencial; USD 120.000 - 170.000; Tempo integral

Resumo da vaga

FUJIFILM Cellular Dynamics is seeking a Senior Process Engineer to join the Process Development (PD) team in Madison, WI. You will serve as a technical authority for late-stage clinical and commercial process development of iPSC-derived therapies, driving scale-up, characterization, and lifecycle planning.

You will collaborate with PD leadership and cross-functional teams to ensure scientifically sound, robust processes aligned with regulatory expectations and client needs, while mentoring

Qualificações

• PhD in biosciences or bioengineering with 2+ years experience or Master’s with 5+ years or Bachelor’s with 7+ years, industry experience preferred.
• Experience leading late-stage clinical and commercial process development activities for biopharmaceutical manufacturing processes.
• Strong background in Quality by Design, process validation, GMP manufacturing, and tech transfer.

Responsabilidades

• Independently plan and lead process development activities for multiple programs.
• Evaluate technologies to improve understanding, robustness, scalability, and GMP readiness.
• Provide technical leadership for late-stage process development, including scale-up, design space, and lifecycle planning.
• Apply regulatory and quality requirements (ICH, FDA, GMP) to ensure compliant processes.
• Analyze complex data, troubleshoot, and recommend process improvements to equipment and methods.
• Mentor junior engineers and lead small to mid-sized development projects.

Conhecimentos

Process development

GMP

Leadership

DOE / DoE

Data analysis

Regulatory understanding

MSAT collaboration

Formação

PhD in biosciences or bioengineering

Master's degree in related field

Bachelor's degree in related field

Ferramentas

Bioreactors

Process characterization

Descrição da vaga

FUJIFILM Cellular Dynamics is seeking a Senior Process Engineer to join the Process Development (PD) team in Madison, WI. You will serve as a technical authority for late-stage clinical and commercial process development of iPSC-derived therapies, driving scale-up, characterization, and lifecycle planning.

You will collaborate with PD leadership and cross-functional teams to ensure scientifically sound, robust processes aligned with regulatory expectations and client needs, while mentoring