Senior Upstream Process Science & Validation Lead

Lundbeck; København; On-site; DKK 786,000 - 1,081,000; Full time

Job summary

Lundbeck seeks a Senior Manager and Team Lead for Upstream PSV to guide a team of experts across mammalian upstream processes, technology transfer and validation. You will set strategy, allocate resources, and ensure high-quality delivery for GMP and regulatory readiness.

You will report to the Senior Director for PSV in CMC Biologics and work with external CMOs, Process Development and Quality. This role is based in Valby, Denmark, with a focus on scientific leadership and continuous

Qualifications

• Master's or PhD in a relevant field with substantial industrial CMC experience.
• Deep understanding of mammalian upstream processes, tech transfer and process validation.
• Proven leadership, project management and cross-functional collaboration.

Responsibilities

• Lead and develop the Upstream PSV team, including resource planning and performance development.
• Provide scientific direction for CMO-executed upstream activities and PPQ readiness.
• Guide scopes, timelines, and technical strategies across projects.
• Ensure cross-functional collaboration with Process Development, Downstream PSV, QRM and Regulatory CMC.
• Contribute to regulatory submissions and health authority interactions.
• Foster continuous improvement of PSV standards and ways of working.

Skills

Leadership

Upstream process knowledge

Validation expertise

CMC Biologics experience

Stakeholder management

English communication

Education

Master's or PhD in biotechnology/biochemistry/pharma sciences/chemical engineering

Tools

LIMS

Regulatory submission systems

Job description

Lundbeck seeks a Senior Manager and Team Lead for Upstream PSV to guide a team of experts across mammalian upstream processes, technology transfer and validation. You will set strategy, allocate resources, and ensure high-quality delivery for GMP and regulatory readiness.

You will report to the Senior Director for PSV in CMC Biologics and work with external CMOs, Process Development and Quality. This role is based in Valby, Denmark, with a focus on scientific leadership and continuous