Senior Research Scientist in Production Process Development - Denmark
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- Do you have the knowledge and experience it takes to break new land and develop production processes for inject-able drug products of the future?
- As we are the link between our research unit and our production we are responsible for developing formulation and production processes, all the way from early development to phase III clinical trials and registration. So if you find this exciting please keep reading!
About the department
- Inject-able Formulation & Process Development is part of Chemistry, Manufacturing and Control (CMC) Development and we are organised in R&D.
- The department has approximately 60 employees in total.
- The team is responsible for production processes development for both our new liquid and our new freeze dried inject-able products.
- We offer you a 12 month temporary position, where you will have responsibility for production process development in order to secure optimal transfer from lab scale development to pilot and productions scale while ensuring pharmaceutical characteristics and stability.
- The development projects in the department include all injectables comprising Glucagon Like Peptide 1 (GLP-1) products, insulins, haemophilia products, monoclonal antibodies and growth hormones.
- Your daily work will be in close collaboration with a project team and you will for example, design, interpret and report production process development studies for drug product, write reports for internal and external use including clinical trial documentation.
- You will interact with a wide variety of internal stakeholders, e.g. Production (Product Supply), Regulatory affairs, Quality Assurance, Analytical Development, Production Pilot Plant and Discovery. Together with your colleagues you contribute to the on-going optimization of processes and systems with LEAN as the guiding light.
- You have a PhD or a M.Sc. within Pharmacy, Engineering of related field of study backed by a minimum 5 year of working experience within drug product development.
- You are experienced in production process development for liquid and/or freeze dried injectables.
- Furthermore, you are familiar with documentation, including regulatory and quality aspects of drug development projects.
- You have strong communication skills both verbally and written in English and it is an advantage but not a requirement if you are able to handle spoken and written Danish.
- As a person, you possess drive and a positive mind-set, you enjoy working in a team with highly motivated people dedicated to developing the next generation of pharmaceuticals.
- You have good collaborative skills and you act flexible in cooperation within the department and with stakeholders.
- At the same time, you also thrive on being the inspirer and guide to your colleagues.
Working with Us:
- We are an organisation with many international employees and we welcome local as well as non-local applicants.
- We offer an inspiring and ambitious working environment, alongside the flexibility that allows you to influence your own working day.
- We believe that is what stimulates the ingenuity to develop the next generations of cutting-edge treatments.
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.