Senior Director, Process Development Operations

FUJIFILM Biotechnologies; Center (IN); On-site; USD 180,000 - 240,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking an experienced technology transfer leader to drive scale-up from development to large-scale production at the Morrisville facility, with a focus on delivering on-time, compliant programs across global sites.

The role requires extensive experience in tech transfer, digital manufacturing optimization, and cross‑functional leadership, partnering with sales and regulatory teams to ensure successful product introductions and ongoing customer support.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field with 12+ years of experience in the pharmaceutical, biotechnology, or CDMO industry, with significant expertise in technology transfer and scaling processes.
• Master’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field with 8+ years of experience in the pharmaceutical, biotechnology, or CDMO industry, with significant expertise in technology transfer and scaling processes.
• Ph.D. in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field is preferred.
• 10+ years’ experience managing, leading, and developing people, with 4+ years’ experience leading and developing team leaders.
• Strong experience in implementing process developments and technological improvements within manufacturing environments.
• Comprehensive knowledge of regulatory compliance and industry standards related to technology transfer and manufacturing.
• Proven track record of managing complex technology transfer projects and digital manufacturing optimization on a global scale.
• Strong understanding of scaling processes from development to large-scale production.
• Customer-facing experience to partner with and support the commercial sales team.

Responsibilities

• Lead and manage technology transfer projects across global sites.
• Scale processes from development to large-scale production while ensuring quality and compliance.
• Partner with commercial teams to enable product launches and customer satisfaction.
• Drive digital manufacturing optimization and audit readiness.
• Develop and mentor leaders and high-performing cross-functional teams.
• Coordinate with regulatory bodies to ensure compliance and harmonization across regions.

Skills

Tech transfer

Scaling

Regulatory compliance

Digital manufacturing

People management

Cross-functional collaboration

Global project management

Customer-facing

Education

Bachelor’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field

Master’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field

Ph.D. in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field (preferred)

Job description

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field with 12+ years of experience in the pharmaceutical, biotechnology, or CDMO industry, with significant expertise in technology transfer and scaling processes.
• Master’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field with 8+ years of experience in the pharmaceutical, biotechnology, or CDMO industry, with significant expertise in technology transfer and scaling processes.
• Ph.D. in Engineering, Biotechnology, Chemistry, Pharmaceutical Science, or related field is preferred.
• 10+ years’ experience managing, leading, and developing people, with 4+ years’ experience leading and developing team leaders.
• Strong experience in implementing process developments and technological improvements within manufacturing environments.
• Comprehensive knowledge of regulatory compliance and industry standards related to technology transfer and manufacturing.
• Proven track record of managing complex technology transfer projects and digital manufacturing optimization on a global scale.
• Strong understanding of scaling processes from development to large-scale production.
• Customer-facing experience to partner with and support the commercial sales team.

Work Arrangement

• This position is on-site 5 days a week at the Morrisville, NC facility in Research Triangle Park.

What Success Looks Like

• On-time, on-quality program delivery with outstanding customer satisfaction.
• Tech transfer velocity and quality become the signature strengths of FLBU.
• High-performing teams with clear standards, empowered leaders, and consistent execution.
• Audit readiness and digital enablement that improve speed, reliability, and transparency.