Biologics Drug Product Lead - Late-Stage & Validation

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

Job summary

Lundbeck seeks a Senior Specialist, Drug Product to drive end-to-end DP activities from early development through regulatory approval and handover to commercialization. You will act as a technical expert in late-stage development, Process Characterization and Process Validation, shaping best practices and supporting colleagues across the portfolio.

You will lead process design, tech transfer and PPQ, while ensuring robust aseptic fill-finish processes and compliant regulatory documentation.

Qualifications

• Bachelor's, Master's or PhD in engineering, chemistry, biological science or equivalent.
• 8+ years of aseptic fill-finish manufacturing, biologics DP development, or PV/MT.
• Experience with late-stage DP development and validation, including Phase III and PPQ.
• Ability to author and review technical and CMC regulatory documents.
• Strong communication across functions and cultures.

Responsibilities

• Execute DP activities across the development lifecycle from early to regulatory approval.
• Lead process design, tech transfer, PC and PPQ for assigned projects.
• Define late-stage DP and validation strategies for MAA/BLA filing and commercial handover.
• Oversee CDMO PC and PV activities, including risk assessments and data evaluation.
• Author and review technical and CMC regulatory documentation.
• Travel internationally as needed.

Skills

Aseptic fill-finish

Process validation

Regulatory documentation

cGMP knowledge

Stakeholder management

Cross-functional collaboration

Technical leadership

English communication

Education

Bachelor's degree

Master's degree

PhD

Job description

Lundbeck seeks a Senior Specialist, Drug Product to drive end-to-end DP activities from early development through regulatory approval and handover to commercialization. You will act as a technical expert in late-stage development, Process Characterization and Process Validation, shaping best practices and supporting colleagues across the portfolio.

You will lead process design, tech transfer and PPQ, while ensuring robust aseptic fill-finish processes and compliant regulatory documentation.