Senior Director, Process Development Operations

Fujifilm

Job Location:

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

Lead a powerhouse team at the heart of Fujifilm Biotechnologies growth. As Senior Director Process Development Operations you will own end-to-end PD delivery at our Morrisville NC site (FLBU)accelerating tech transfers elevating technical excellence and ensuring on-time on-quality program outcomes that delight customers and fuel the business. Youll sit on the site leadership team helping to shape the U.S. PD Center of Excellence and influencing standards across our network.

This is a highly visible cross-functional leadership role for a builder who thrives at the intersection of science execution and client engagement.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What youll do

Serve as executive sponsor for key programsfrom kick-off to closeoutaligning teams managing milestones proactively mitigating risk and ensuring transparent client communication.
Make tech transfer speed and quality a competitive advantagestandardize integrate and optimize new facilities platforms and practices across PD.
Drive operational excellence across Upstream Downstream Analytical Development integrated AD/QC labs MSAT and the clinical cGMP manufacturing interface.
Set clear goals and performance indicators; track progress recognize achievements and rapidly address gaps to deliver on time within budget and to the highest quality standards.
Lead and develop senior leaders and their teams; foster a culture of collaboration innovation and continuous improvement with psychological safety and high accountability.
Orchestrate cross-functional decisions with Program Management QA/QC Manufacturing Engineering Supply Chain Finance EHS HR IT/Digital and Commercial to meet customer and business outcomes.
Own PD operating performancecapacity planning resource allocation fixed cost control and operating budgetwith measurable impact on revenue margin and site utilization.
Champion harmonization across global sites; standardize methods documentation and digital tools (e.g. MES/LIMS/eQMS/ERP integrations).
Ensure audit-ready compliance with cGMP GLP/GDocP data integrity/ALCOA and quality systems; support inspections due diligence and high-stakes client forums.

Why this role matters

You will convert strategy into execution that enables clinical supply accelerates commercial handover and strengthens customer trust.
Your leadership sets the bar for cycle time right-first-time and cost-to-servedriving competitive advantage for FLBU and the broader Fujifilm Biotechnologies network.
Your voice shapes network standards and investment priorities with direct influence on outcomes that matter to patients and partners.

What youll bring (minimum requirements must have)

Bachelors degree in Engineering Biotechnology Chemistry Pharmaceutical Science or 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; or
Masters degree in Engineering Biotechnology Chemistry Pharmaceutical Science or 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 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 tech transfer and manufacturing.

Preferred qualifications

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 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.

Why join us

Impact at scale: Your leadership accelerates life-changing therapies to patients.
Visibility and influence: Operate at site and global levels with real ownership and accountability.
Collaborative culture: Partner with world-class experts across PD QA/QC Manufacturing and Commercial in a mission-driven environment.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Exec

Position OverviewLead a powerhouse team at the heart of Fujifilm Biotechnologies growth. As Senior Director Process Development Operations you will own end-to-end PD delivery at our Morrisville NC site (FLBU)accelerating tech transfers elevating technical excellence and ensuring on-time on-quality p...