Manufacturing Specialist, Tech Transfer

Make a direct impact bringing lifesaving therapies from partner sites to GMP manufacturing. As a Manufacturing Specialist – Tech Transfer, you will lead and execute end-to-end drug substance tech transfers from external partners/CMOs into our site, coordinating cross-functional activities, ensuring process and documentation readiness, supporting scale-up and validation (PPQ), and enabling efficient, compliant start-up of commercial or clinical production.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What you’ll do

• Tech transfer planning and execution
• Translate process knowledge into site-ready procedures, batch records, and control strategies.
• Help design and review equipment/line fit, scale-up parameters, sampling plans, and process acceptance criteria.
• Coordinate cross-functional activities to drive right-first-time transfer and start-up.
• Process readiness and documentation
• Review and assess manufacturing documentation, training materials, and readiness packages.
• Ensure manufacturing instructions, bill of materials, and operational controls are accurate and effective for floor execution.
• Validation and control strategy
• Support PPQ strategy, protocol development, execution, and reporting.
• Partner with MSAT/PD to define CPPs/CMAs, control limits, and in-process control (IPC) strategy aligned to the control strategy.
• Deviation/CAPA and change management
• Assist in investigations for engineering, qualification, and tech transfer batches; contribute to root cause and CAPA development.
• Implement and manage changes through formal change control, ensuring alignment to filings and site procedures.
• Cross-functional leadership
• Serve as the primary interface among Manufacturing, MSAT/PD, QA, QC, Validation, Supply Chain, EHS, and external partners/CMOs.
• Lead/participate in tech transfer meetings, stage-gate reviews, and provide status reports to leadership.
• Compliance and inspection readiness
• Ensure activities align with cGMPs, site procedures, and regulatory filings (CMC).
• Support audits/inspections and provide SME coverage on transferred processes and control strategy.
• Shop-floor support
• Provide on-the-floor coverage during engineering, qualification, and PPQ runs; coach operators/technicians.
• Troubleshoot process issues, driving timely resolution and documentation.
• Continuous improvement
• Identify opportunities to streamline transfer workflows, documentation, and training to accelerate readiness while maintaining compliance.
  

Minimum education and experience requirements Candidates must meet one of the following:

• High School Diploma/GED and 10 years of related experience, OR
• Associate’s degree, preferably in life sciences or engineering, with 8 years of direct experience, OR
• Bachelor’s degree, preferably in life sciences or engineering, with 6 years of direct experience, OR
• Equivalent Military experience/training
  
  

And

• Strong cGMP manufacturing operations experience
• Understanding of operations sequence and cadence of activities
• Prior experience in updating and creating manufacturing documents per schedule
  
  

Preferred Experience

• Biologics (mAbs, viral vectors, vaccines) and/or sterile fill-finish/aseptic processing experience
• Single-use technologies, cell culture, and chromatography/UFDF
• Familiarity with MES/EBR, LIMS, and equipment automation (e.g., SCADA/DeltaV)
• External manufacturing/CMO tech transfer experience
  
  

Core competencies

• Technical depth with practical, hands-on problem-solving
• Structured project management and prioritization under time pressure
• Stakeholder management and clear, concise communication
• Ownership, accountability, and a safety-first mindset
  
  

Work conditions

• On-site role with frequent shop-floor presence; some off-shift/weekend support during campaigns
• Physical requirements: Ability to work in cleanroom/controlled environments, gowning, and lift up to [5] lbs as needed
  
  

Why this role

• Drive visible results by transferring and launching critical therapies safely and compliantly
• Collaborate across Manufacturing, MSAT/PD, QA/QC, Validation, Supply Chain, and external partners
• Grow your technical and leadership skills in a high-impact, GMP environment
  
  

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to 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 (FDBN_PNC@fujifilm.com).