Senior Upstream Process Leader & PSV Team Lead

Lundbeck A/S, H; København; On-site; DKK 786,000 - 1,081,000; Full time

Job summary

Lundbeck invites applications for a Senior Manager and Team Lead Upstream Process Science & Validation in Copenhagen. You will lead a talented team of Upstream SMEs within PSV and guide technical direction for CMO-executed activities from transfer to validation and PPQ readiness.

You will collaborate across Process Development, Downstream PSV, Regulatory CMC and External Manufacturing to ensure robust upstream processes and timely regulatory submissions.

Qualifications

• Master’s or PhD in a relevant field with industrial biopharmaceutical CMC experience.
• Strong leadership experience and people-development skills.
• Deep upstream process knowledge including cell culture and bioreactor operation.
• Experience with CMOs and external manufacturing partners.
• Experience with regulatory submissions and health authority interactions.

Responsibilities

• Lead and develop the Upstream Process Science & Validation team, including resource planning and performance management.
• Provide scientific direction and oversight for CMO-executed upstream activities, including tech transfer and GMP manufacturing support.
• Define scopes, timelines, deliverables, and risk-based technical strategies across projects.
• Ensure cross-functional collaboration and timely issue resolution for Module 3 submissions and health authority questions.
• Strengthen PSV standards and ways of working across functions and partners.

Skills

People leadership

Upstream process knowledge

CMO coordination

Regulatory submissions

English communication

Biopharmaceutical CMC

Process characterization

Technology transfer

Education

Master’s degree or PhD in biotechnology, biochemistry, pharmaceutical sciences, chemical engineering or another relevant field

Job description

Lundbeck invites applications for a Senior Manager and Team Lead Upstream Process Science & Validation in Copenhagen. You will lead a talented team of Upstream SMEs within PSV and guide technical direction for CMO-executed activities from transfer to validation and PPQ readiness.

You will collaborate across Process Development, Downstream PSV, Regulatory CMC and External Manufacturing to ensure robust upstream processes and timely regulatory submissions.