Analytical project Manager for synthetic API

Analytical project Manager for synthetic API

Category: Quality **Location:**Høje-Taastrup, Capital Region of Denmark, DK

Location: Høje-Taastrup.

Join Novo Nordisk synthetic API & Contract manufacturing and help deliver analytical excellence for chemically synthesized Active Pharmaceutical Ingredients (APIs). We are seeking an Analytical Project Manager who will act as both project manager and subject matter expert (SME) for analytical activities performed at Contract Manufacturing Organizations (CMOs) and within our new Analytical Science & Technology & Quality Control (ASAT & QC) function.

The Position

We are looking for an Analytical project Manager for our department for chemical synthesized Active Pharmaceutical Ingredients (APIs), who can fulfill the role both as project manager and SME on analytical subjects.

You will act as analytical project manager within our development projects and lead all drug substance analytical activities from post phase 3 to commercialization.

Key responsibilities will include:

• Coordinating analytial cativities both at CMOs and internally
• Lead preparation and coordination of regulatory submissions for development projects (e.g., NDAs/MAAs/DMFs)
• Ensure in collaboration with the CMO(s) that analytical methods are compliant and robust for market use
• Define and lead the analytical strategy towards market launch
• Represent the analytical drug substance area in internal and external governance boards
• Review, discuss and approve CMO-related documents (validation protocols, validation reports, analytical procedures)
• Provide subject matter expertise on method lifecycle management and analytical troubleshooting

You will collaborate within Novo Nordisk on a global scale and with external CMOs and acquired companies. This will present a variety of challenges, that requires fostering an open, positive atmosphere to ensure a strong cross-functional collaboration with your colleagues. Given that many CMOs are internationally based, the position involves some travel (less than 14 days a year is expected) and meetings outside of normal working hours.

Qualifications

To succeed in this role, you have:

• A degree (B.Sc./ M.Sc./ PhD) in Pharmacy, Chemistry, Biochemistry, Chemical Engineering, or other similar scientific discipline. Thus, good understanding of aspects of molecular science.

• Have a minimum of 5 years of experience in a similar position, ideally within the pharmaceutical sector

• Experience with late phase (phase 3 and ongoing) pharmaceutical development projects

• Experience with GMP, ICH guidelines and regulatory requirements to ensure compliance.

• Working with method validation is part of your experience

• Scientific experience working with analysis of synthesized API is an advantage

• Previous experience with regulatory submission is considered an advantage

• Full professional proficiency in English

As we are a new area different processes still need to be established, whereas you need to be able to show strong leadership skills and communication when steering the project through challenges where minimal guidance exists.

As a person, you thrive on a high level of flexibility and adaptation, enabling you to excel in a role where the quality of your work is paramount. You have “a firm hand” when it comes to science and possess good skills at communicating with all types of stakeholders both verbally and in writing, and you are motivated by the opportunity to expand your network within our field.

About the Department

External Analysis & QC is a department currently with teams based in USA and Danmark. This position is based in Høje Taastrup, Denmark.

The team consists of Analytical Project Managers & analytical scientists. The team is very diverse from origin, and we are very proud of it.

What we offer

At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary: For this role, the Annual Base Salary ranges from 651,000.00 to 956,900.00 DKK, corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area, and relevant market benchmarks. Learn more about our Reward Philosophyhere.

Deadline: 23 of August. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.

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.