Lead Process Engineer – iPSC Cell Therapy Development

Merck & Co.; Madison (WI); On-site; USD 110,000 - 170,000; Full time

Job summary

FUJIFILM Cellular Dynamics in Madison, WI is seeking a Senior Process Engineer to lead late-stage process development for iPSC-derived therapies within the Process Development team. The role emphasizes scalable manufacturing processes, technology transfer, and collaboration with clients to ensure regulatory readiness.

You will mentor junior engineers, apply DOE and process characterization, and deliver robust, phase-appropriate strategies while maintaining quality and schedule commitments in a

Qualifications

• PhD in a biosciences or bioengineering discipline plus at least two years of related experience; or a Master's with five years; or a Bachelor's with seven years; industry experience preferred
• Leading late-stage clinical and commercial process development activities for biopharmaceutical manufacturing
• Experience with scalable upstream and/or downstream unit operations in cell manufacturing
• Strong understanding of Quality by Design, process validation, and GMP requirements for tech transfer
• Experience partnering with MSAT, Manufacturing, Quality, Analytical Development, and other teams
• Ability to develop and defend technical strategies using scientific and engineering principles
• Strong written and verbal communication with diverse stakeholders
• Experience mentoring engineers and scientists within process development
• Strong problem-solving and project-management skills
• Flexibility to support after-hours as needed
• Ability to maintain hands-on lab presence
• Ability to lift up to 50 pounds
• Ability to work with hazardous materials and PPE
• Ability to operate in a regulated environment

Responsibilities

• Independently conceive, plan, and lead process development activities for multiple programs.
• Evaluate and implement technologies to improve robustness, scale-up, and GMP readiness.
• Provide technical leadership for late-stage clinical and commercial development.
• Apply regulatory and quality requirements to ensure phase-appropriate activities.
• Analyze complex data, troubleshoot, identify root causes, and recommend improvements.
• Make risk-based decisions and clearly communicate technical tradeoffs.
• Develop and maintain compliant technical documentation and records.
• Communicate findings and project status to cross-functional teams and clients.
• Collaborate to meet timelines, quality, regulatory, and transfer needs.
• Provide training and mentorship to junior engineers; lead small to mid-size projects.
• Identify innovative, potentially patentable process improvements.
• Perform other duties as assigned.

Skills

Process development

Late-stage development

Scale-up & tech transfer

Regulatory knowledge (ICH, GMP)

Data analysis / DOE

Mentorship

Cross-functional collaboration

Problem solving

Education

PhD in biosciences or bioengineering

MS in related field + 5+ years

BS in related field + 7+ years

Tools

Bioreactors

Cell culture

Statistical analysis

Job description

FUJIFILM Cellular Dynamics in Madison, WI is seeking a Senior Process Engineer to lead late-stage process development for iPSC-derived therapies within the Process Development team. The role emphasizes scalable manufacturing processes, technology transfer, and collaboration with clients to ensure regulatory readiness.

You will mentor junior engineers, apply DOE and process characterization, and deliver robust, phase-appropriate strategies while maintaining quality and schedule commitments in a