Senior Process Engineer - Cell Therapy PD & Scale-Up

FUJIFILM Cellular Dynamics, Inc; Madison (WI); Presencial; USD 120.000 - 170.000; Tempo integral

Resumo da vaga

FUJIFILM Cellular Dynamics, Inc. is seeking a Senior Process Engineer for the Process Development team in the Madison, WI area. You will lead late‑stage process development for iPSC‑derived therapies, partnering with clients to ensure robust, scalable, and compliant manufacturing processes.

The role emphasizes technical leadership, cross‑functional collaboration, and hands‑on bench work to advance projects from development through technology transfer while maintaining high quality standards.

Qualificações

• PhD/masters/bachelor’s with years of experience in biopharma or CDMO settings.
• Experience leading late‑stage clinical and commercial process development.
• Strong knowledge of GMP, QbD, and regulatory expectations.

Responsabilidades

• Independently plan and lead process development for multiple programs.
• Evaluate technologies to improve robustness, scalability, and GMP readiness.
• Provide technical leadership for late‑stage clinical processes and scale‑up.
• Apply regulatory requirements to ensure scientifically sound development.
• Analyze complex data, troubleshoot, and propose improvements.
• Document development plans, reports, risk assessments, and control strategies.
• Communicate findings to cross‑functional teams and clients.
• Mentor junior engineers and lead small‑mid projects.
• Identify potential process improvements and patentable ideas.

Conhecimentos

Lead process development

GMP manufacturing

Quality by Design

Process characterization

Scale-up

Cross-functional collaboration

Mentorship

Data analysis

Formação

PhD in biosciences / bioengineering

Master's in related field

Bachelor's in related field

Descrição da vaga

FUJIFILM Cellular Dynamics, Inc. is seeking a Senior Process Engineer for the Process Development team in the Madison, WI area. You will lead late‑stage process development for iPSC‑derived therapies, partnering with clients to ensure robust, scalable, and compliant manufacturing processes.

The role emphasizes technical leadership, cross‑functional collaboration, and hands‑on bench work to advance projects from development through technology transfer while maintaining high quality standards.