Senior Specialist

Senior Specialist, QC CMC Biologics

Do you want to join our global CMC Biologics Quality Control team? And are you eager to work in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Senior Specialist!

Your new role

As our Senor Specialist, you will be:

• Technical lead and subject matter expert for Quality Control activities with primary focus on drug substance
• Supporting drug substance Process Performance Qualification (PPQ) activities
• Working closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities, e.g., sampling plans, specifications, Certificate of Analysis, stability studies, method validation etc.
• Reviewing and approving QC testing data, protocols, reports, and other documents for studies performed internally and at contract laboratories
• Collaborating within project teams including Process Development, Process Science and Validation, Analytical Development, Quality Assurance, Regulatory CMC and Corporate Product Quality Control
• Supporting regulatory filings and other interactions with Health Authorities including authoring and/or reviewing of INDs, IMPDs, and BLA

This position is a great opportunity where you will be part of a team ensuring the quality of Lundbeck’s development biological drugs from Phase I to Phase III before transfer to the commercial team. Some travelling, on average 2-4 trips per year, is estimated in this role.

Your future team

In CMC Biologics, we are more than 100 employees, split between Lundbeck Headquarters in Copenhagen, Denmark and Lundbeck Process Development Center of Excellence in Seattle, WA, USA. Most of the teams in the CMC Biologics organization have employees based in both Copenhagen and Seattle; this is also the case for your new team, Quality Control. You will work out of the headquarters in Valby, Copenhagen, and will report to the Senior Manager Quality Control, in Valby. Your colleagues in the Quality Control team are all experienced specialists, and together we are responsible for the quality of Cell Banks, Drug Substance, and Drug Product for all Lundbeck development biological projects.

CMC Biologics support the development and production of new biologics drug candidates for diseases like Migraine, Multiple System Atrophy, and neurohormonal dysfunctions. Established CMC Biologics focus team and task force teams are responsible for the continued development of Lundbeck’s Biologics candidates and the project teams include representatives from Manufacturing Science (upstream and downstream), Drug Product Technology, Regulatory Affairs, Quality Assurance, and Quality Control.

As our team is located both in Copenhagen and Seattle, it is necessary to accommodate to the time zone difference for meetings. We aim to reduce late meetings to a minimum by maintaining a primary meeting band in the calendar and by applying a geographical proximity, when working with our global CMOs.

The position is based in Valby, Copenhagen - Denmark.

What you bring to the team

You are a highly skilled Senior Specialist with minimum 9 years of experience in the biotech or pharmaceutical industry. You have an accredited MSc or PhD in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal. In addition, you bring:

• QC experience with drug substance PPQ and late-stage QC deliverables in preparation for BLA filing
• Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia, ICH guidelines and GDP/GMP guidelines
• Understanding of methods used to test biological molecules (e.g., SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA)
• Advanced English verbal and written communication skills
• Demonstrated knowledge in method transfer, method validation, stability testing, and specification evaluation

As a person, you enjoy working in cross-functional teams and have the ability to work effectively in teams in a fast-paced environment with evolving priorities. You have effective verbal communication and collaboration skills, along with good written communication skills and the ability to summarize scientific data in an organized, clear, and persuasive manner.

In addition, you bring a quality mindset, and you are motivated by teamwork, openness, continuous improvement, and career development. 

Candidates fulfilling most but not all the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications.

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.

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.

Applications must be received by 15 June 2026.

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

#EveryBrainInTheGame

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.