Finished Drug Product Specialist for CMO/External Manufacturing

At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial product portfolio includes market-leading vaccines against smallpox, mpox, rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization, striving to improve people's health and quality of life worldwide, protecting our tomorrow.

The role
We are seeking an experienced specialist for CMO – Finished Drug Product (FDP) at our site in Kvistgaard, Denmark. You will report to the Head of FDP CMO Operations and become part of the External Manufacturing team with +25 employees located in Denmark, the US, Switzerland, and Germany.

As the Specialist for FDP, your main responsibility is to ensure better quality and yield by building and supporting the improvement of systems at the CMOs. Internally, your stakeholders are Quality Control, Quality Assurance, MSAT, Supply Chain, Regulatory Affairs, and others. As part of your role, you will establish and foster alignment with all relevant stakeholders.

Another key responsibility is to drive and support Performance Qualification (PQ) and Process Validation (PV) activities. You will apply your knowledge and experience in close collaboration with the CMOs and internal stakeholders, ensuring the robust setup of present and new production processes.

In this role, you will be the subject matter expert for assembly and packaging, supporting strategic projects and providing critical input to secure efficient, compliant, and scalable solutions.

We already apply A3 problem-solving methodologies in our collaboration with CMOs, and we are now looking to further strengthen our approach by leveraging these practices to bring added structure, data-driven insights, and continuous improvement.

Finally, you will play a central role in ensuring that our CMOs meet expectations, with the mandate to escalate issues where needed and drive resolution in partnership with both internal and external teams.

Other Tasks

• Being a key player in the CMO core teams
• Supporting CMO managers with problems, change controls, and other related GMP documentsRunning deviation reports
• Running and supporting change controls
• Ensuring the CMO processes are being optimized and implementing a process for improvements
• Ensuring Batch Manufacturing Records and other documents are correct
• Running and supporting improvement activities at our CMOs       

What you bring
To become a success in this role, it is evident that you bring solid experience from similar roles – spiced with implementation knowledge for A3 You hold strong communication skills, an eye for detail, and can convert the details into a simple explanation so others understand. Besides this, you are a team player and can take on challenges and strive to find implementable solutions.

A Master of Science in a relevant field and at +4 years of experience in packaging and assembly processes within the pharmaceutical industry are required. Experience with vaccines and syringe assembly this is a plus.

Why This Role

In this role, you’ll be the go-to expert for assembly and packaging, shaping how new production processes are qualified and validated in partnership with CMOs. You’ll work closely with internal teams and external partners, gaining strong cross-functional exposure and influence. As we already use A3 problem-solving and now want to strengthen our data-driven improvements, you will join at a time to help us improve and leverage our maturity. Most importantly, your expertise will ensure that high-quality medicines reach patients reliably, making your impact both strategic and meaningful.

Application

If you are ready to take on a pivotal role in a growing organization and drive meaningful change in healthcare, apply now and join Bavarian Nordic in our mission to improve health outcomes and foster sustainable growth.

We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.

Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us at Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Www.Bavarian-Nordic.Com

#Li-Ck1