Manufacturing Specialist, Tech Transfer

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.
• Affirm 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.