Drug Product Responsible

Bagsværd

Are you looking for an opportunity to play a key role in developing new injectable drug products to treat serious chronic diseases? Do you thrive in a high paced environment where you change the way we work, shaping the future of manufacturing at [xxxxx]?
In New Product Introduction (NPI), we are looking for an academic or engineer with a can-do-attitude, who is comfortable working with a high level of responsibility to join our team.
If you are looking for an opportunity to work with stability and specification of new products, and to have an impact on the future of diabetes and obesity products, you might be the person we are looking for in the NPI Drug product team. The position
As scientist/senior scientist you will be allocated a primary drug product, and as drug product responsible you set the stability strategy and participate in ensuring the control strategy.
Your responsibilities will include submission as well as questions and answers to authorities.
Main tasks:
  • As product responsible in New Product Introduction you will work with late-stage clinical injection products within our areas of diabetes and obesity.
  • You will be involved with several development projects and your responsibilities will include data analysis, documentation, reporting and managing project within our department.
  • You will work in close collaboration with development, Regulatory Affairs and manufacturing sites and you will design, interpret, and report stability studies on drug products.
  • We offer you a creative work environment and your quality conscious and flexible mindset is important in our team as you will be working in a changing environment.
  • Furthermore, the position as scientist / senior scientist comes with great possibilities of developing your professional and personal competences. Qualifications
    We are looking for a colleague who is great with knowledge sharing and thrives in an environment full of interesting challenges. You can see the value in finding solutions by thinking outside the box and challenging the status quo.
    Ideally, you have:
  • Preferably, you hold a M.Sc. or PhD within pharmaceutical science, Biotechnology, Biochemistry, Chemistry, Biophysics, or another relevant scientific field.
  • You might have experience working with drug product stability, specifications, and data analysis.
  • You are comfortable with analyzing stability data, writing reports (both internal and external) and communicating with stakeholders from several levels in an organization.
  • Professional competence in both written and spoken English.
  • You have a strong personal drive that is reflected in your desire to take initiative and have an impact on the business, as well as taking responsibility for your own learning and development. About the department
    New Product Introduction is a part of Product Supply, in the area Injectable Finished Products (IFP) Manufacturing Development. The department consists of approximately 80 employees split into to 6 teams in Bagsværd.
    The main responsibility of NPI is bringing products from late-stage development to large scale production. Our team is responsible for product stability studies, regulatory documentation, and transition of development products from development to large scale production. You will be a part of a great team of people with individual competencies that work together to meet deadlines and team goals. Working at [xxxxx]
    At [xxxxx], we don’t wait for 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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
    For further information, please contact Associate Manager, Sara Eisenhardt at +[xxxxx] Deadline
    24 June 2024 Please note that applications will be assessed on an ongoing basis and therefore the advert may close before the recruitment process is completed if we have proceeded with candidates to the screening or interview phase. 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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    • 10.06.2024
    • Øvrige
    • Bagsværd