Manufacturing Specialist, Tech Transfer

Fujifilm•Holly Springs, NC

9d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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
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

Responsibilities

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.
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.
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.
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.
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.
Ensure activities align with cGMPs, site procedures, and regulatory filings (CMC).
Support audits/inspections and provide SME coverage on transferred processes and control strategy.
Provide on-the-floor coverage during engineering, qualification, and PPQ runs; coach operators/technicians.
Troubleshoot process issues, driving timely resolution and documentation.
Identify opportunities to streamline transfer workflows, documentation, and training to accelerate readiness while maintaining compliance.