Senior Specialist, Drug Product

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

Become one of Lundbeck's go-to subject-matter experts (SMEs) for biologics drug product development from Phase I through regulatory approval and launch. You will lead Drug Product (DP) activities end-to-end on assigned projects while strengthening our department's capabilities and standards in late-stage development, process characterization and process validation.

Your new role

As our Senior Specialist, Drug Product, you will execute DP activities across the development lifecycle, from early clinical development through regulatory approval and commercial handover.

You will also act as a technical expert in late-stage development, Process Characterization (PC) and Process Validation (PV), helping to establish best practices and supporting colleagues across the portfolio. You will apply this expertise directly in your own projects, leading process design, control strategy, technology transfer, PC and PPQ to establish robust, registration-ready aseptic fill-finish processes.

• Execute drug product activities for assigned projects, including process design, technology transfer, PC and PPQ.
• Define and maintain technical standards and best practices for late-stage development and validation, supporting colleagues across the portfolio.
• Define late-stage DP and validation strategies for assigned projects, including MAA/BLA filing and commercial readiness.
• Take technical ownership of CDMO’s PC and PV activities, including risk assessments, protocols, deviation assessments and data evaluation.
• Oversee technology transfer and manufacturing campaigns, including on-site support when needed.
• Author and review technical and CMC regulatory documentation; support health authority interactions, commercial handover and continued process verification.

Your future team

CMC Biologics comprises approximately 100 colleagues across Copenhagen, Denmark, and Seattle, United States. You will report to the Senior Director for Drug Product Technology and join a department of 12 SMEs working with formulation, drug product and combination product activities.

Each SME leads activities end-to-end on assigned projects while contributing specialist expertise across the wider portfolio.

You will collaborate across Formulation Development, Drug Product, Device, Drug Substance, Analytical Development, Quality Control, Quality Assurance, Regulatory CMC and CMC Project Management, as well as with external development and manufacturing partners. Our team culture is based on knowledge sharing, curiosity, constructive challenge and mutual support.

Some international travel (mainly Europe and North America) is expected.

The position is based in Copenhagen, Denmark.

What You Bring To The Team

You hold a bachelor's degree, master's degree or PhD in engineering, chemistry, biological science or an equivalent discipline. In addition, you bring 8+ years of relevant experience in aseptic fill-finish manufacturing, biologics drug product development, manufacturing science and technology, or process validation.

• Demonstrated experience with late-stage DP development and validation, including Phase III, PC and PPQ.
• Strong scientific and technical knowledge of aseptic manufacturing processes and equipment, technology transfer, process design, quality risk management, cGMP and good documentation practice.
• Ability to author and review technical and CMC regulatory documents and apply independent, science‑and risk-based judgment to complex issues.
• A collaborative and influential working style, and the ability to communicate clearly clear communication across functions and cultures.
• Experience working with CDMOs or other external manufacturing partners.
• Solid stakeholder management and communication skills in English.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

Annual base salary range: 786 000 - 1 081 300 DKK gross

At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.

Learn more about us at www.lundbeck.com, LinkedIn or Instagram (@h_lundbeck).