Senior Director, Process Development Operations

FLBU FUJIFILM Life Sciences Biotechnologies U.S.A., Inc.; Morrisville (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

FLBU FUJIFILM Life Sciences Biotechnologies U.S.A., Inc. is seeking a seasoned leader to manage technology transfer processes at their Morrisville, NC facility. Candidates should have over 10 years of experience in the pharmaceutical industry, demonstrating strong leadership and a successful track record in managing technology transfer projects.

This role requires on-site presence five days a week, fostering high-performing teams and ensuring compliance with industry standards while delivering outstanding customer satisfaction.

Qualifications

• 12+ years in pharmaceutical, biotechnology, or CDMO industry.
• Experience managing, leading, and developing teams with at least 4 years in leadership.
• Strong understanding of scaling processes from development to production.

Responsibilities

• Manage complex technology transfer projects.
• Lead technology transfer velocity and quality initiatives.
• Ensure audit readiness and promote digital enablement.

Skills

Leading and developing teams

Implementing process developments

Regulatory compliance knowledge

Managing complex technology transfer projects

Digital manufacturing optimization

Customer-facing experience

Education

Bachelor’s degree in Engineering or related field

Master’s degree in Engineering or related field

Ph.D. in Engineering or related field

Job description

Minimum Education and Experience

• Bachelor’s degree in Engineering, Biotechnology, Chemistry, Pharmaceutical Science or a related field is required 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 a related field is required 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 a related field is preferred.

Minimum Experience and Qualifications

• 10+ years’ experience managing, leading and developing people, including 4+ years of 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 tech transfer and manufacturing.

Preferred Experience

• 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.

Success Criteria

• 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.