Senior Stability Scientist for synthetic manufacturing platforms

2 weeks ago

Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

Select how often (in days) to receive an alert: Create Alert

Senior Stability Scientist for synthetic manufacturing platforms

Category: Manufacturing

Location:

Høje-Taastrup, Capital Region of Denmark, DK

Are you a skilled stability scientist with good understanding of ICH stability requirements, statistics and/or chemical manufacturing, and want to use your GMP knowledge to support the growth of our synthetic manufacturing platforms? Then you could be our new colleague.

The position
We are looking for a Senior Stability Scientist with good understanding of the regulatory requirements for API stability of chemical entities to drive and ensure the successful execution of stability programmes conducted at external contract manufacturing organizations.

The preferable candidate is experienced in the design and handling of API stability studies as well as the evaluation and trending of stability data for commercial phase products. Knowledge of organic chemistry and/or peptide chemistry is a strong advantage.

Your main tasks will include the following:

  • Support and maintain overview of the growing portfolio of stability studies for chemically synthesized APIs across the synthetic manufacturing platforms.
  • Support the design and planning of stability studies at external collaborators to document product quality and establishment of retest period/shelf-life.
  • Authoring of internal and external reports and shelf-life statements and handling urgent issues with the stability with potential impact on product together with product and process responsible.
  • Statistical evaluations, data analysis, calculations, and quality statements/rationales.
  • Review and approve stability protocols and reports for studies conducted at CMOs.

This job gives you a unique opportunity to work with multiple stakeholders including Late-Stage Development, Analytical Functions, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot facilities, production facilities, and external partners.

Some travel activities can be expected (visit at CMO's). The position does not involve practical work in the laboratory.

Qualifications
To succeed in the role, we expect that you have some of the below qualifications and are eager to learn any remaining required skillset:

  • Ph.D. or M.Sc. in chemistry, chemical engineering, or equivalent
  • Experience with GMP stability for APIs, preferably small molecules and/or peptides along with knowledge of ICH guidelines relevant to API stability.
  • Experience within CMC and/or Manufacturing Development (or MSAT) and experience with statistical tools, e.g. JMP
  • Experience with analytical chemistry is an advantage
  • Proficiency in English.

As a person, you possess a solution-oriented mindset with a strong practical capability to convert theoretical knowledge into practical solutions for technical challenges. Your ability to communicate and collaborate effectively with internal and external stakeholders across different disciplines in both development and production is highly valuable. Your positive attitude enables you to work efficiently, whether as a team player or independently, on complicated tasks, ensuring timely progress.

About the department
As part of Novo Nordisk's Product Supply organization, you will be part of Emerging Technologies API Manufacturing Science and Technology (ET API MSAT). We receive projects from CMC with a focus on process understanding, implementation, optimization, and life cycle management. We are responsible for Ph3 and commercial stability studies.
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.
The department is newly established, presenting a unique opportunity to join at the beginning of an exciting journey, while benefiting from the established way of working in Novo Nordisk.

Working at Novo Nordisk
At Novo Nordisk, we don't wait for a change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we're all working to move the needle on patient care.

Contact
For further information, please contact Sr. manager Camilla Christensen, + 45 30 79 17 67 or Area specialist Masood Hosseini +45 34 44 01 98

Deadline
17 March 2025.
Applications are reviewed on an ongoing basis, so please submit your application 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 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 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 the communities we operate in. Together, we're life changing.

#J-18808-Ljbffr

  • Senior Stability Scientist for Synthetic Manufacturing Platforms Expert

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    As a Senior Stability Scientist at Novo Nordisk A/S, you will play a pivotal role in driving the successful execution of stability programmes conducted at external contract manufacturing organizations. Your expertise in regulatory requirements for API stability of chemical entities will be crucial in maintaining overview of the growing portfolio of stability...

  • Stability Scientist for Next-Generation Manufacturing

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Novo Nordisk A/S is a dynamic company in a rapidly changing industry, and we're always looking for talented individuals to join our team. As a Senior Stability Scientist, you will have the opportunity to work with multiple stakeholders including Late-Stage Development, Analytical Functions, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot...

  • Leading Figure in API Stability Science

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Join us at Novo Nordisk A/S as a Senior Stability Scientist and contribute to our mission of creating a world without limitations for people with diabetes and other serious chronic diseases. As part of Emerging Technologies API Manufacturing Science and Technology (ET API MSAT), you will receive projects from CMC with a focus on process understanding,...

  • Senior Quality Professional in Small Molecules Manufacturing

    1 week ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Job Overview:As a Senior Quality Professional in Small Molecules Manufacturing, you will play a key role in ensuring the quality and compliance of our small molecule products. This position is part of our QA for Manufacturing Development team, which covers the diverse area of Manufacturing Development. Your responsibilities will include reviewing and...

  • Project Director within Development Product Portfolio, Technology Platform Lead for Chemical APIs

    3 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Category: Project Management & AgileLocation: Høje-Taastrup, Capital Region of Denmark, DKDo you thrive in tackling complex challenges and shaping strategic decisions? Are you ready to provide expert guidance on manufacturability and scalability while driving optimization across Novo Nordisk's product development pipeline? Join us as a Technology Platform...

  • Project Director within Development Product Portfolio, Technology Platform Lead for Chemical APIs

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Category: Project Management & Agile Location: Høje-Taastrup, Capital Region of Denmark, DK Do you thrive in tackling complex challenges and shaping strategic decisions? Are you ready to provide expert guidance on manufacturability and scalability while driving optimization across Novo Nordisk's product development pipeline? Join us as a Technology Platform...

  • Experimental Equipment Development Scientist

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark ATLANT 3D Full time

    Job Title: Experimental Equipment Development ScientistCompany: ATLANT 3D NanosystemsLocation: Taastrup, DenmarkReports to: New Technology Group LeadAbout ATLANT 3D:ATLANT 3D Nanosystems is at the forefront of the Atomic Scale Manufacturing Era, driving innovation with cutting-edge technologies that revolutionize advanced materials and micro/nanodevice...

  • Senior Application Engineer/Scientist

    24 hours ago

    Taastrup, Høje-Taastrup Kommune, Denmark ATLANT 3D Full time

    Join ATLANT 3D, a leader in advanced energy solutions and sustainable technologies. We are dedicated to pioneering breakthroughs in catalysis, electrocatalysis, fuel cells, and battery systems to drive the future of clean energy. If you are passionate about developing innovative applications that make a real-world impact, we invite you to be part of our...

  • Senior Project Manager

    2 days ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking an experienced Senior Project Manager to lead and manage projects in drug product manufacturing. As a key member of our team, you will be responsible for driving complex cross-functional projects, maintaining portfolio overview, and overseeing project management processes.Key ResponsibilitiesLead and manage projects in drug...

  • Manager of Advanced Manufacturing Systems

    3 days ago

    Taastrup, Høje-Taastrup Kommune, Denmark ATLANT 3D Nanosystems ApS Full time

    Technical Program ManagerATLANT 3D Nanosystems ApS is seeking an experienced Technical Program Manager to lead projects that push the boundaries of semiconductor thin film process equipment. As a key member of our team, you will guide a talented group of engineers and scientists, ensuring seamless integration of theory, innovation, and practical...

  • API Manufacturing Expert

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Position SummaryWe are seeking a seasoned Technology Platform Lead to join our team at Novo Nordisk A/S. As a key member of our team, you will be responsible for providing technical expertise and strategic guidance to support development projects and portfolios.Main AccountabilitiesProvide expert guidance on manufacturability and scalability for clinical and...

  • Senior Manager Thin Film Deposition Equipment

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark The HubDanske Bank Full time

    Company OverviewATLANT 3D is a pioneer in micro and nanofabrication technologies. Our mission is to develop groundbreaking solutions that drive the era of atomic-scale manufacturing.We're looking for a talented individual to lead our projects, guiding a team of engineers and scientists in transforming early concepts into market-ready solutions.Job...

  • Quality Assurance Specialist for Emerging Technologies

    1 week ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Job Description:We are seeking an experienced Quality Assurance Specialist to join our Emerging Technologies QA team at Novo Nordisk. The successful candidate will play a critical role in ensuring the quality and compliance of our novel manufacturing methods, products, and technologies.About the Role:This position is part of our QA for Manufacturing...

  • Senior Director of External Manufacturing

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    We are looking for a seasoned leader to fill the position of Director for Aseptic Processes. The successful candidate will be responsible for leading our team in implementing new production processes at Contract Manufacturing Organisations (CMOs).The ideal candidate will have a strong background in scientific research, preferably in chemistry, pharmacy, or...

  • Senior Nanotechnology Project Manager

    4 days ago

    Taastrup, Høje-Taastrup Kommune, Denmark ATLANT 3D Nanosystems ApS Full time

    About UsATLANT 3D Nanosystems ApS is a pioneering company in the field of micro and nanofabrication technologies. We are committed to developing innovative solutions that drive the era of atomic-scale manufacturing.The RoleWe are seeking an experienced Technical Program Manager to lead projects that push the boundaries of semiconductor thin film process...

  • Senior Quality Assurance Specialist

    1 week ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    We are seeking a seasoned Sr. Quality Assurance Specialist - Contract Manufacturing to join our Global Contract Manufacturing (GCM) Quality Assurance team. As a key member of our team, you will be responsible for ensuring the quality of analysis and methods related to testing of out-sourced raw materials, intermediates, and starting materials.In this role,...

  • Senior Contract Manufacturing Leader

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    About Us: At Novo Nordisk, we're driven by a purpose to make a difference in the lives of people with chronic diseases. Our team is passionate about creating innovative medicines that improve the quality of life for millions of patients worldwide.">About the Department: The GCM DS Operations department is responsible for the daily operations of our global...

  • Experimental Equipment Designer

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark ATLANT 3D Full time

    Job SummaryThis role will focus on designing, developing, and testing experimental equipment for atomic-scale manufacturing. The ideal candidate will have a strong academic background in Mechanical Engineering, Electrical Engineering, Materials Science, Physics, or a related field and relevant experience in experimental equipment development.The successful...

  • Scientific Instrumentation Engineer

    2 weeks ago

    Taastrup, Høje-Taastrup Kommune, Denmark ATLANT 3D Full time

    About ATLANT 3DWe are at the forefront of the Atomic Scale Manufacturing Era, driving innovation with cutting-edge technologies that revolutionize advanced materials and micro/nanodevice manufacturing.Our mission is to accelerate advanced technologies' innovation and empower businesses to deliver breakthrough applications with unmatched speed and quality.We...

  • Senior QA Professional for small molecules

    1 week ago

    Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Category:QualityAre you passionate about setting direction within emerging technologies and ensuring compliance? Do you have experience within small molecules? Are you skilled in navigating complex stakeholder landscapes and motivating teams to deliver great results? Do you thrive in a constantly changing environment with various challenges and growth...