Senior Analytical Project Manager

Are you looking for an exciting opportunity to lead the implementation of analytical methods for new drug products?
 
If you have a strong foundation in analytical chemistry and are eager to enhance your project management skills, read on! We are seeking an engaged and passionate individual who can drive our projects to success. 
 

The position
As Senior Analytical Project Manager you will play a key role in leading analytical development activities across different products. Activities include coordination of analytical validations, regulatory documents, submissions to and questions from authorities across the globe. You will be a member of the core project team along with other technical project managers.

Your main responsibilities will include:

• Interact with a wide variety of stakeholders such as technical project managers (for e.g., drug product and drug substance), CMC, Quality Assurance, Regulatory Affairs, and representatives from Quality Control departments.
• Collaborate and coordinate with analytical professionals within your department who are working hands-on with method validation and optimisation, new technology and regulatory writing.
• Be responsible for aligning the needs of the project organization with those in line of business.
• Work closely with stakeholders across the organization regarding both planning and execution and resolving concrete scientific challenges.

 
You will be responsible for aligning the needs of the project organisation with those in line of business. You will work closely with stakeholders across the organisation regarding both planning and execution, and in resolving concrete scientific challenges. All of this require clear and timely communication of project requirements to team and department members.
Finally, you will join a harmonious team and department with competent, caring, and positive colleagues. We have a strong foundation of employees with high seniority mixed with more recent newcomers.
 
Qualifications
 You will be a great asset to our team because you have:

• A relevant academic degree within Pharmacy, Chemistry, Engineering or a similar field.
• Experience in managing and executing smaller and larger projects within CMC analytical development and/or QC 
• Extensive experience in leading analytical activities in either early phase and/or late phase clinical development.
• Scientific experience within analytical development and/or validation and experience with regulatory submissions, combined with knowledge of GMP requirements
• Experience in transfer of analytical methods and CMO collaboration is an advantage.
• Full professional proficiency in English.

 
On a personal level, you enjoy working on both short and long-term projects in implementing new products and processes. You are naturally good at communicating with all types of stakeholders both verbally and in writing. This helps you to keep all your stakeholders aligned, informed, and engaged. You are motived by the opportunity of getting a large network in and across our area.’

About the department
The Analytical Competence Centre is a department in AMSAT and consists of 65 employees organized in 5 teams. We have a central support function in relation to chemical analysis of Novo Nordisk injectable finished products under development, as well as our marketed products. The department is responsible for validation of analytical methods for late-phase development and market products and thereafter for the following transfer of the analytical methods to our QC laboratories across the world. Furthermore, the department is scouting, testing, and implementing fast analytical techniques that can reduce the lead time for analysis with the ambitious long-term goal of real time release testing of injectable finished products.
 
Working at Novo Nordisk
At Novo Nordisk we use our skills, dedication, and ambition to help people with diabetes/other chronical diseases and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
 
Contact 
For further information, please contact Senior Manager Markus Kaldan Back on +45 3075 0510.
 
Deadline 
5 December 2024

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.