Development Scientist for Raw Material qualification

4 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Manufacturing

Ansøg nu

Are you ready for a career in the pharmaceutical industry and join a growing area taking part in the development of the future Novo Nordisk product pipeline? Are you looking for an opportunity to apply and develop your skills within raw materials for GMP production, process, project & stakeholder management? And do you thrive working with high complexity tasks and improvement projects focusing on digital solutions and automated processes?

If yes, then we have the right challenge for you within the expanding GMP Raw Materials team in CMC API Process Operations as our new Development Scientist for Raw Material qualification. Come join us in helping more than forty million patients world-wide.

Novo Nordisk – ranked as #1 "Best Place to Work" in 2023.

The Position
In CMC API Process Operations we are a dedicated team ensuring safe and compliant GMP materials for innovative treatments, including Advanced therapy medicinal products (ATMPs) for GMP production to all of Novo Nordisk clinical trials globally.

As Material Responsible you will ensure the suitability of materials for GMP production to clinical trials from the entire Novo Nordisk development portfolio e.g. Cell Therapy. We are divided into two teams with different areas of responsibilities.

You will be our representative in the CMC project teams and bridge between project management, process development, the Cell Therapy Unit, CMC API Pilot facilities and facilities in the US. Your stakeholders will also include multiple different experts within Novo Nordisk, such as virologists and microbiologists.

Your responsibilities will include but not be limited to:

  • GMP material Qualification of different types of materials (raw materials, consumables, excipients) including Setting the internal release specification for the warehouse and quality control (QC).
  • Close contact and collaboration with various external stakeholders such as material suppliers, logistics services etc., to obtain sufficient knowledge to ensure patient safety, GMP, and GDP compliance.
  • Collaboration with internal stakeholders to ensure proper scientific evaluations in documentation packages.
  • Participation in supplier assessment and auditing.

Furthermore, you will drive optimizations and projects to improve our working processes. This is a truly important part of the job, as it is essential for our business continuity that focus is on simplicity and adaptability, as new information continuously drives us to change priorities or direction.

We offer an exciting and developing position as part of a dynamic and multidisciplinary team focusing on simplicity and adaptability in their daily work. As the teams grow, new tasks and opportunities are continuously added to the team.

Qualifications
You hold a relevant Master or PhD degree within a field of scientific expertise such as but not limited to Engineering, Biology, Biochemistry or similar. In addition, we are looking for candidates with the following qualifications:

  • GMP experience in the pharmaceutical industry preferably from a similar role
  • Coordinating tasks within a large project with many different stakeholders
  • Excellent communication skills and proficiency in both spoken and written English
  • Great collaboration skills with a good sense of priority and not afraid to set direction.
  • A team-player who enjoys cross-functional, cross-departmental and stakeholder collaboration.

We have open positions in both teams and are looking for profiles with various levels of seniority and experience. We are open to experienced senior profiles as well as newly graduated profiles with relevant pharmaceutical or manufacturing experience.

The Department
As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture, and distribute drug candidates for clinical trials and have a strong culture with a "can do" mind-set.

The department CMC API Process Operations is a part of CMC API development and consists of 100+ colleagues organized in 8 teams. CMC API Process Operations plays a key role in securing the patient safety in the clinical trials from the entire Novo Nordisk development portfolio.

The two GMP materials teams consist of around 10 colleagues in each team. We are located in Søborg, and we enjoy social interaction through coffee breaks, walking/running and dining together. The position is office based, but we do offer flexibility by working from home up to 2 times a week if the task at hand allows it.

Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That's why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 68,000 employees. Together, we go further. Together, we're life changing.

Contact
For further information, please contact Associate Manager Sara Jersie Hjelholt at +45 3077 7594 or Louise Rosendahl Strunge +45 3077 5016.

Deadline
15 September 2024

Please submit your application as fast as possible as we will review applications and invite for interviews on a continuous basis. Several positions are available.

You do not need to write a cover letter but please include 10-15 lines about your motivation in the CV, highlighting your key skills and contributions to the position.

Please avoid the use of photos in your CV. This makes for a better and more fair process.

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.

#J-18808-Ljbffr

  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job OverviewWe are seeking a highly skilled Materials Scientist for Raw Material Qualification to join our dynamic team at Novo Nordisk A/S. As a key member of our CMC API Process Operations department, you will play a vital role in ensuring the safety and compliance of GMP materials for clinical trials.About the RoleIn this exciting opportunity, you will be...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About UsAt Novo Nordisk A/S, we strive to make a real difference for patients with chronic diseases across the world. Our CMC API Process Operations department is a critical part of this mission, ensuring the safe and compliant GMP materials for clinical trials.The PositionAs a Materials Scientist for Raw Material Qualification, you will be an integral part...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the Job:The GMP Raw Materials Specialist will be responsible for ensuring regulatory compliance, assessing vendor change notifications, and providing strategic input on raw material-related matters. This role requires collaborating with Supplier Qualification Management, Procurement, QA, and Process Teams to assess material and supplier risks. You will...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the Role:The Biopharmaceutical Material Scientist Lead will be responsible for facilitating and evaluating the introduction of new raw materials and single-use systems (SUS) into AGC Biologics. This role requires generating and overseeing Change Requests for the introduction, modification, and discontinuation of raw materials/SUS. You will develop and...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the JobWe are looking for an experienced Principal Research Chemist to join our QC Raw Material team at AGC Biologics. In this role, you will be key in implementing new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.Key ResponsibilitiesRaw material specification...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    The TeamOur CMC API Process Operations team is dedicated to securing patient safety in clinical trials across the Novo Nordisk development portfolio. As a Materials Scientist for Raw Material Qualification, you will work closely with 100+ colleagues organized into 8 teams, each with unique areas of responsibility.About the DepartmentCMC API Process...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job OverviewThe QC Raw Material team at AGC Biologics is seeking a highly skilled Senior/Principal Scientist to support the implementation of new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.Main ResponsibilitiesDevelop and review raw material specifications based on...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job DescriptionAs a Senior Manager for Raw Materials Procurement at Novo Nordisk, you will be responsible for leading a team of 15 dedicated Supply Managers and Quality Professionals within the RAW category. This involves building and optimizing Novo Nordisk's supply chain for all raw materials, engaging and optimizing supplier performance by structurally...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About AGC Biologics:We are a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. Our purpose is to bring hope to life by enabling life-changing therapies for patients...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Join a dynamic and international company where everyone is responsible for delivering right on time as one team The Position By joining the QC Raw Material team, you will be key in implementing new raw materials to support new phase I/II projects as well as planning the Raw Material Qualification and Release Testing program for late stage projects. As part...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. Team leader/Manager, Material Science Team Are you an experienced...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the JobAs a Quality Assurance Scientist at AGC Biologics, you will support Supply Chain, Process Transfer, and QC for late-stage and commercial products.Key responsibilities include closing collaborations with internal stakeholders, change control, deviation handling, and CAPAs, reviewing and approving material specifications, releasing raw materials...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionWe are seeking an experienced QC Lead to join our Formulation Development team at AGC Biologics. In this role, you will be responsible for supporting the implementation of new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.Main TasksRaw material...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job Overview">We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.This role is part of our development...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job DescriptionWe are looking for a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. As a member of our team, you will support CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.Your key responsibilities will...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job DescriptionWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. As a key member of our team, you will support CMC API Development within the raw material and CMO shipping area.Your Responsibilities:Ensure compliance with regulatory requirements, quality standards, and company policies.Deliver...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. AGC Biologics is looking for an experienced QA scientist to assist with...


  • Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About AGC BiologicsAGC Biologics is a global Contract Development Manufacturing Organization (CDMO) providing comprehensive biologics manufacturing services. Our team tailors each client's needs for turnkey manufacturing or sophisticated analytical, formulation, and stability services.We have facilities in Europe, Japan, Italy, and the USA, enabling us to...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job OverviewThe successful candidate will be responsible for securing quality agreements with external suppliers and ensuring that raw materials for our products are used in clinical trials following the information provided to Health Authorities worldwide.Key Qualifications:MSc in Pharmaceutical Sciences, Engineering, Biochemistry, or similar.At least 1...


  • Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About the RoleThis position involves supporting CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.You will be responsible for delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product...