Senior Process Engineer - Cell Therapy Development

FUJIFILM Biotechnologies; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Cellular Dynamics, based in Madison, WI, seeks a Senior Process Engineer to lead late-stage process development for iPSC-derived cell therapies within the PD team. This onsite role focuses on robust, scalable manufacturing processes, regulatory alignment, and close collaboration with clients and cross-functional teams.

You will drive process characterization, scale-up studies, and lifecycle planning while mentoring junior staff and delivering high-quality results for complex programs.

Qualifications

• PhD or MS/BS tracks with required years of experience in biopharma process development.
• Experience leading late-stage clinical and commercial process development activities.
• Strong knowledge of regulatory expectations (ICH, FDA, GMP) and tech transfer.

Responsibilities

• Independently conceive, plan, and lead process development activities for multiple programs.
• Evaluate technologies to improve process understanding, robustness, and GMP readiness.
• Provide technical leadership for characterization, scale-up, design space, and lifecycle planning.
• Communicate strategies and results to cross-functional teams and clients.
• Mentor junior engineers and lead small-to-mid sized projects as assigned.
• Identify innovative process improvements and potential patentable ideas.

Skills

Process development leadership

Scale-up / tech transfer

GMP regulatory knowledge

Risk assessment & DOE

Cross-functional collaboration

Mentorship

Education

PhD in biosciences or bioengineering or closely related field

MS in related field with 5+ years of experience

BS in related field with 7+ years of experience

Job description

FUJIFILM Cellular Dynamics, based in Madison, WI, seeks a Senior Process Engineer to lead late-stage process development for iPSC-derived cell therapies within the PD team. This onsite role focuses on robust, scalable manufacturing processes, regulatory alignment, and close collaboration with clients and cross-functional teams.

You will drive process characterization, scale-up studies, and lifecycle planning while mentoring junior staff and delivering high-quality results for complex programs.