Starting Material Subject Matter Expert (SME)

Do you want to play a key role in securing robust, compliant, and future‑proof starting materials for commercial vaccines used worldwide? Are you motivated by owning complex technical topics end‑to‑end; from late‑stage development and commercial manufacturing to regulatory strategy and lifecycle management? 

Then you might be our new Starting Material Subject Matter Expert (SME). 

About the job 

We are looking for an experienced scientific professional to join our Global Manufacturing Science & Technology (gMSAT) organization. In this role, you will act as the global expert for vaccine starting materials, including master and working cell banks, virus seeds, and related lifecycle activities. You will define strategy, challenge assumptions, and ensure alignment across sites, functions, and regulatory frameworks. You will work alongside other senior SMEs with own areas of responsibilities. 

This is a senior, visible role with significant influence. You will often operate as the primary expert within your knowledge domain, collaborating closely with stakeholders across the organization - and occasionally leveraging external knowledge and networks to stay at the forefront of best practices. 

Your impact 

As Starting Material SME, you will ensure that our vaccines are built on a solid scientific and regulatory foundation. You will provide strategic oversight of starting material lifecycles, anticipate risks before they become issues, and support sustainable commercial supply through informed decision-making on scale, shelf life, replenishment, and end-of-production strategies. 

Your work will directly support supply reliability, regulatory compliance, and long‑term product success for late‑phase and commercial products. 

Your key responsibilities 

Your responsibilities will span strategy, governance, and hands‑on expert support, including: 

• Define and own the global strategy for starting materials, including cell banks and virus seeds, and end‑of‑production approaches 
• Establish and maintain global procedures, standards, and technical requirements for starting material lifecycle management 
• Maintain a holistic overview of starting material status, identifying what is critical now and what will become critical in the future 
• Drive forecasting and capacity planning for starting materials in collaboration with manufacturing, supply chain, and sites 
• Assess and enable shelf‑life extension opportunities and replenishment strategies where scientifically and regulatorily justified 
• Provide expert input to development activities, including introduction of new or more stable cell lines 
• Act as a regulatory sparring partner, challenging requirements where appropriate and defining what is minimally sufficient while remaining compliant 
• Support and represent starting material topics in regulatory filings, health authority interactions, inspections, and audits 
• Ensure clear roles and responsibilities across functions related to ownership, forecasting, release, and renewal of starting materials 
• Systematize and document knowledge to ensure transparency, continuity, and long‑term robustness 
• Provide expert scientific support to deviations, investigations, and change controls related to starting materials 

Are you our next expert? 

You will thrive in this role if you enjoy owning complex topics, working independently while influencing many stakeholders, and combining strong scientific judgement with pragmatic regulatory thinking. 

We imagine that you bring several of the following qualifications and experiences - but we encourage you to apply even if you do not meet every single requirement: 

• Advanced degree (MSc or PhD) in biotechnology, virology, molecular biology, pharmaceutical sciences, or a related field 
• Solid experience with late‑phase or commercial biologics/vaccine products 
• Deep knowledge of cell banks, virus seeds, and starting material lifecycle management in a GMP environment 
• Strong understanding of global regulatory expectations (e.g. ICH Q5D, EMA/FDA) and lifecycle activities such as variations, stability, and comparability 
• Experience contributing to or leading regulatory submissions, responses, or inspections 
• Ability to challenge and interpret regulations with scientific confidence and sound risk‑based judgement 
• Strong stakeholder management and communication skills, enabling alignment across sites and global functions 
• Fluency in written and spoken English 

About you 

As a person, you are structured, reflective, and comfortable being the go-to expert in your field. You can zoom out to see the full lifecycle while still diving deep into technical detail when needed. You work independently, but value collaboration, knowledge sharing, and constructive challenge. 

Why join us? 

• Be part of a company with a strong purpose: delivering vaccines that protect public health globally 
• Take ownership of a strategically important expert role with high visibility and impact 
• Work in a collaborative, international environment with engaged and knowledgeable colleagues 
• Influence how future vaccines are developed, supplied, and maintained over their full lifecycle 
• Enjoy attractive facilities and employee benefits, including a vibrant staff community 

Application 

As part of the recruitment process, we ask you to prepare a short motivation text where you:

• Motivate your interest in the role of Starting Material Subject Matter Expert (SME) at Bavarian Nordic.
• Address the competencies and experiences requested in the job posting. 
• Conclude a short reflection on why you are a strong match for the role.

Deadline: 17th of May 2026 

Apply by clicking the ‘APPLY’ button. We are interviewing on an ongoing basis and look forward to receiving your CV.

We expect to start interviews in week 21. 

Please note that for this position, we do not support any relocation packages. 

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

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.  

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. 

For more information, visit www.bavarian-nordic.com  

#LI-MO1