Analytical Project Manager
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Gentofte
Are you ready to apply your project management experience in an exciting organization, where you will get challenged, grow, and expand your capabilities to the fullest? Do you want to be a part of the development of future drugs and make a difference in our vision to change the life of patients with rare diseases? Then, apply now for a life-changing career! The position
As 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.
• 3+ years of experience in managing and executing smaller and larger projects.
• 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.
• 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
You will become a part of Biotech and Rare Disease (BRD) Analytical Manufacturing Development. We validate and optimise analytical methods for new products within haemophilia and other rare diseases based on new technologies. We develop analytical methods to reduce lead time, or to increase yield or capacity in production facilities and QC laboratories. Working with various kinds of tasks and professional challenges, we use our professional skills combined with systematic problem solving. We have innovation in focus, and we implement new technologies continuously.
Working at BRD, Novo Nordisk
BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are more than 3000 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we are also striving to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career?
Contact
For further information, please call Manager, Lina Ilia +45 34482752.
Deadline
12 May 2024. But please apply as soon as possible as we will be conducting interviews on an ongoing basis.
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 in your CV. 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.
As 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.
• 3+ years of experience in managing and executing smaller and larger projects.
• 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.
• 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
You will become a part of Biotech and Rare Disease (BRD) Analytical Manufacturing Development. We validate and optimise analytical methods for new products within haemophilia and other rare diseases based on new technologies. We develop analytical methods to reduce lead time, or to increase yield or capacity in production facilities and QC laboratories. Working with various kinds of tasks and professional challenges, we use our professional skills combined with systematic problem solving. We have innovation in focus, and we implement new technologies continuously.
Working at BRD, Novo Nordisk
BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are more than 3000 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we are also striving to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career?
Contact
For further information, please call Manager, Lina Ilia +45 34482752.
Deadline
12 May 2024. But please apply as soon as possible as we will be conducting interviews on an ongoing basis.
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 in your CV. 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.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Gentofte.
Jobbet er oprettet på vores service den 16.4.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Projektleder
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