Sr Reference Material Professional

Senior Reference Material Professional (Level 7)

REQ 343770

Location: Måløv, Denmark

Job Category: Research & Early Development

Are you an experienced pharmaceutical scientist who enjoys working in a combined setup with both coordination activities and preparation of detailed documentation that directly support the development of life-changing medicines?

Would you like to play a pivotal role in ensuring analytical reference materials are available throughout the entire pharmaceutical development lifecycle from early clinical development through to commercial manufacturing?

Do you thrive in a collaborative environment where scientific expertise, regulatory documentation, stakeholder management and continuous improvement are equally important?

If so, you could be our new Senior Reference Material Professional within Analytical Development at Novo Nordisk.

About the Department

You will join the Reference Materials team within Analytical Development, part of Analytical Characterisation in Chemistry, Manufacturing & Control (CMC).

The team is responsible for establishing reference materials for analysis of drug substance and drug product to support the entire development portfolio at Novo Nordisk. Our work spans from early Phase I development through Phase II, Phase III, and regulatory submissions.

Although part of Analytical Development, this is not a laboratory-based role. Instead, the team acts as the scientific hub for all reference material activities, ensuring high-quality documentation, regulatory compliance and timely delivery across the development projects.

As our portfolio continues to grow, we are strengthening our reference material team to support increasingly complex development projects across Novo Nordisk.

The Position

As a Senior Reference Material Professional, you will independently coordinate reference material activities across a broad portfolio of pharmaceutical development projects.

You will become responsible for ensuring reference materials are established by preparing the necessary documentation, coordinating the related activities and follow the stability of the batches throughout the product lifecycle while supporting regulatory submissions.

This role combines scientific understanding with coordination, preparation of high-quality documentation, stakeholder management and regulatory documentation in a highly collaborative environment.

Please note: Although this role coordinates numerous scientific activities and projects, it is not a traditional Project Manager position. We are looking for an experienced scientific professional who enjoys combining technical expertise with documentation, stakeholder collaboration and working in a structured scientific environment within a GMP-regulated pharmaceutical environment.

Your Responsibilities

As Senior Reference Material Professional you will:

• Lead reference material activities across multiple development projects simultaneously.
• Coordinate reference material activities (laboratory and large-scale production, labelling, analysis, storage and distribution).
• Prepare, review and maintain scientific documentation (protocols, reports and regulatory documentation).
• Prepare and maintain CMC regulatory documentation supporting CTA, BLA and MAA submissions.
• Respond to Health Authority questions relating to reference materials.
• Support lifecycle management activities including stability programmes, establishment of new batches and shelf-life extensions.
• Work closely with Analytical Project Managers while acting as the subject matter expert for reference materials.
• Collaborate with colleagues across Analytical Development, API, Manufacturing, Regulatory Affairs, Quality and Global Research.
• Ensuring GMP compliance and maintaining high documentation standards.
• Identify opportunities to improve existing processes while supporting digitalisation and continuous improvement initiatives.

What We're Looking For

To succeed in this position, you will likely have:

• MSc or PhD in Pharmacy, Chemistry, Biochemistry, Biotechnology or another relevant scientific discipline.
• Significant experience within the pharmaceutical or biotechnology industry.
• Strong experience within Chemistry, Manufacturing & Control (CMC) or Analytical Development.
• Excellent understanding of GMP and pharmaceutical quality systems.
• Experience preparing scientific and regulatory documentation.
• Strong project coordination skills.
• Excellent written and spoken English.

The following would be advantageous:

• Experience within CMC.
• Analytical Development experience.
• Knowledge of Reference Materials.
• Regulatory documentation experience.
• Experience answering Health Authority questions.
• Pharmaceutical quality systems.
• Previous Reference Material experience is considered an advantage but is not essential, as this is a highly specialised area and training will be provided.

About You

Success in this role depends as much on your behaviours as your technical expertise.

You are someone who enjoys creating structure within complex scientific environments and naturally builds strong relationships across multidisciplinary teams.

You are diplomatic, collaborative and able to influence others through credibility rather than authority.

You recognise yourself in the following:

• Excellent planning and organisational skills.
• Strong scientific judgement.
• Highly organised with exceptional attention to detail.
• Able to work independently while knowing when to involve colleagues.
• Comfortable coordinating multiple projects simultaneously.
• Excellent stakeholder management skills.
• Calm under pressure.
• Naturally curious with a continuous improvement mindset.
• Proactive and solution oriented.
• Comfortable challenging existing processes constructively and respectfully.
• Motivated by improving ways of working rather than changing them for the sake of change.
• We are looking for someone who can integrate into an experienced specialised team, bringing fresh ideas while respecting established expertise and building trust through collaboration.

Why Join Novo Nordisk?

Joining our Reference Materials team offers the opportunity to become part of one of Novo Nordisk's most specialised scientific functions.

You will work alongside experienced scientists supporting the entire pharmaceutical development pipeline while influencing how reference materials are managed across global development projects.

This role offers excellent opportunities to broaden your scientific expertise, collaborate internationally and contribute directly to the development of medicines that improve the lives of millions of patients worldwide.

Working at Novo Nordisk

At Novo Nordisk, your skills, commitment and ambition help improve the lives of millions of people living with serious chronic diseases.

We offer an inspiring working environment where you will have the opportunity to influence how Reference Materials are managed across an expanding development portfolio while working alongside highly skilled colleagues in an international organisation committed to innovation, quality and continuous development.

Salary & Benefits

Novo Nordisk offers a competitive reward package including a salary in the range of 651,000 to 956,900 DKK per year, annual bonus, pension, private healthcare and a comprehensive benefits package, together with outstanding opportunities for professional and personal development within one of the world's leading pharmaceutical companies.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.