(Senior) Development Scientist for Raw Material qualification

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Are you looking for a career in the pharmaceutical industry, where you can apply and develop your skills within raw materials for GMP production, process, project & stakeholder management? Are you motivated to join a growing area taking part in the development of future [xxxxx] product pipeline and help more than forty million patients world-wide? And are you ready to take on the challenge of working with high complexity tasks and improvement projects focusing on digital solutions and automated processes? If yes, then this opportunity within the expanding GMP Raw Materials team in CMC API Process Operations could be right for you. We encourage all EU-citizens to apply as relocation to Denmark will be an option for relevant candidates. Come join us and [xxxxx] – 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 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 responsibilities will include but not be limited to:
  • Coordination, introduction, qualification and life cycle management of different types of materials (raw materials, consumables, excipients) for GMP production to clinical trials from the entire [xxxxx] development portfolio e.g. Cell Therapy.
  • Ensure that the suitability of materials is properly evaluated based upon the intended use.
  • 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.
    • Your stakeholders will also include multiple different experts within [xxxxx], such as virologists and microbiologists. You will collaborate with your internal stakeholders on complex issues to ensure proper scientific evaluations in our documentation packages. 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 drive 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 team is growing, 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 Engineering, Biology, Biochemistry, Biotechnology or similar, but not limited to. 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, structured, and have a natural sense of priority and not afraid to set direction.
  • A team-player who enjoys cross-functional, cross-departmental and stakeholder collaboration.
    • As several positions are available, we are looking for profiles with different levels of seniority and experience. We are open to experienced senior profiles as well as newly graduated profiles with some relevant pharmaceutical or manufacturing experience. The Department As part of [xxxxx] 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 60+ 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 [xxxxx] development portfolio . Your new team consists of 10 colleagues located in Bagsværd who 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 1-2 times a week if the task at hand allows it. Working at [xxxxx] [xxxxx] 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 [xxxxx] is working toward something bigger than ourselves, and it’s a collective effort. [xxxxx] relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Associate Manager, Sara Jersie Hjelholt at: +[xxxxx]or Associate Manager, Louise Rosendahl Strunge at: +[xxxxx]. Deadline 9 June 2024 Please submit you 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 [xxxxx] 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.


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    Jobbet er oprettet på vores service den 10.5.2024, men kan have været deaktiveret og genaktiveret igen.

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