Tech Transfer Lead

QCS Staffing Ltd; Dublin; Presencial; EUR 95.000 - 140.000; Jornada completa

Descripción de la vacante

QCS Staffing Ltd. seeks a Tech Transfer Lead in Dublin, Ireland for an initial 11-month contract within the life sciences sector. You will drive end-to-end technology transfer for biologics, covering upstream, downstream and analytical transfers in a GMP environment.

The role requires leading cross-functional teams, developing transfer strategies, plans and readiness activities, and providing technical oversight during runs, validation, PPQ campaigns and post-transfer monitoring.

Formación

• Extensive experience in Technology Transfer, MSAT, Process Development, or Manufacturing within GMP-regulated biopharma.
• Strong understanding of biologics drug substance manufacturing, including upstream and downstream processing.
• In-depth knowledge of cGMP regulations, process validation, quality systems and transfer principles.
• Proven ability to lead cross-functional projects, manage stakeholders, identify risks, and drive issue resolution.

Responsabilidades

• Lead end-to-end technology transfer activities for drug substance biologics processes, including upstream, downstream, and analytical transfers.
• Develop and execute transfer strategies, project plans, timelines, risk assessments, and transfer readiness plans.
• Coordinate cross-functional teams across PD, Manufacturing, Quality, Regulatory, Supply Chain, and CDMO partners.
• Provide technical oversight during engineering runs, process validation, PPQ campaigns, and post-transfer performance monitoring.

Conocimientos

Technology Transfer

MSAT

Process Development

Manufacturing

GMP

Descripción del empleo

Tech Transfer Lead - Dublin, Ireland - Initial 11-Month Contract - Life Sciences

Our client is a global leader in pharmaceutical innovation, specialising in the development and manufacture of cutting-edge drugs. As they continue to grow, they're seeking an experienced Tech Transfer Lead to support their dynamic team and drive forward groundbreaking projects in Dublin.

What You'll Deliver

• Lead end-to-end technology transfer activities for drug substance biologics processes, including upstream, downstream, and analytical transfers.
• Develop and execute transfer strategies, project plans, timelines, risk assessments, and transfer readiness plans.
• Coordinate cross-functional teams across Process Development, Manufacturing, Quality, Regulatory, Supply Chain, and CDMO partners.
• Provide technical oversight during engineering runs, process validation, PPQ campaigns, and post-transfer performance monitoring.

What you'll need:

• Extensive experience within Technology Transfer, MSAT, Process Development, or Manufacturing in a GMP-regulated biopharmaceutical environment.
• Strong understanding of biologics drug substance manufacturing, including upstream (cell culture) and downstream processing.
• Extensive knowledge of cGMP regulations, process validation, quality systems, and technology transfer principles.
• Proven ability to lead complex cross-functional projects, manage stakeholders, identify technical risks, and drive issue resolution.