Senior Specialist, Drug Product

Cari; København; Hybrid; DKK 786,000 - 1,081,000; Full time

Job summary

Lundbeck seeks a Senior Specialist, Drug Product, to lead end-to-end DP activities from late-stage development through regulatory approval and handover to commercial teams. You will set technical standards for PC, PV, and aseptic fill-finish processes and drive successful technology transfer across CDMOs and internal partners.

You will collaborate with cross-functional teams to ensure robust, registration-ready processes and maintain high-quality CMC documentation.

Qualifications

• 8+ years of experience in aseptic fill-finish manufacturing and biologics DP development.
• Strong knowledge of cGMP and regulatory documentation.
• Experience with CDMOs or external manufacturing partners.
• Excellent stakeholder management and English communication.

Responsibilities

• Execute DP activities including process design, technology transfer, PC and PPQ.
• Define late-stage DP strategies for DP and validation.
• Oversee tech transfer and manufacturing campaigns.
• Author and review CMC regulatory documents.
• Support health authority interactions and commercial handover.

Skills

Aseptic fill-finish

Biologics DP development

Manufacturing science

Process validation

Education

Engineering or Chemistry degree

Job description

Senior Specialist, Drug Product

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.

Your key responsibilities will include:

• 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 lundbeck/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.

Applications must be received by November 30, 2026 and will be reviewed on an ongoing basis.

If you have questions, Michael Pedersen, Senior Director Drug Product Technology, MIPDLundbeck.

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

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.