Analytical Research Scientist
- Research & Development
- Denmark - Måløv
Do you have the knowledge to contribute to the development of the diabetes products of the future? And do you enjoy working in an open, dynamic and social atmosphere with a strong focus on technical and scientific skills? If so, you have the opportunity to play a key role in CMC Diabetes Analytical Development in Måløv, Copenhagen.
About the department
Department Diabetes Analytical Development is a part of CMC Injectable Protein Formulation in R&D. The department are organised in two analytical teams with a total number of 29 persons. The open position is in team Diabetes Method Development, which consists of 7 scientists and 5 technicians. Acting as the link between the research unit and the production unit the department is responsible for developing analytical methods for new diabetes products – all the way from early development to phase 3 clinical trials and registration. The analytical platform consists mainly of chromatographic methods, HPLC and UPLC.
The job
You will be responsible for development of analytical methods for the next generation of products for diabetes treatment. You will be part of one or more project groups within the analytical development team and refer to the team leader. Your main focus will be to develop analytical methods within UPLC and HPLC techniques in order to support development of drug substances and drug products. The analytical development discipline includes generation of relevant documentation, validation, robustness, stability, characterization support and regulatory documentation.
You will work in a series of diabetes projects in close cooperation with the Research Unit, Formulation Development, Upstream and Downstream API Process Development, Product Supply, Structural Characterization, Quality and Regulatory Affairs.
Together with your colleagues you will contribute to the on-going optimisation of processes and systems using LEAN.
Qualifications
You hold a Master’s degree within Life Sciences (Pharmacy, Engineering or other relevant discipline). A PhD or similar experience is an advantage but not a requirement. You have a minimum of 2 years of practical experience within HPLC/UPLC analytical development in the pharmaceutical industry. You have a good knowledge of general protein chemistry, HPLC/UPLC and validation. Knowledge of GMP/GLP regulatory requirements is an asset. Analytical development is based upon several tools, e.g. Design of Experiments and Mathematical Modelling. Therefore, knowledge hereof is an advantage.
As a person you have a positive and flexible mind-set, which is helpful in an ever changing project environment and enabling you to build fruitful relations to colleagues and stakeholders. You are a team player and contribute to reaching team goals. You have excellent English oral and written communication skills.
At Novo Nordisk, 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.
Contact
For further information, please contact David Nolan at +45 3075 6398 or Karoline Benktander at +45 3075 8013.
Deadline
28 June 2013.
- Research & Development
- Denmark - Måløv
Do you have the knowledge to contribute to the development of the diabetes products of the future? And do you enjoy working in an open, dynamic and social atmosphere with a strong focus on technical and scientific skills? If so, you have the opportunity to play a key role in CMC Diabetes Analytical Development in Måløv, Copenhagen.
About the department
Department Diabetes Analytical Development is a part of CMC Injectable Protein Formulation in R&D. The department are organised in two analytical teams with a total number of 29 persons. The open position is in team Diabetes Method Development, which consists of 7 scientists and 5 technicians. Acting as the link between the research unit and the production unit the department is responsible for developing analytical methods for new diabetes products – all the way from early development to phase 3 clinical trials and registration. The analytical platform consists mainly of chromatographic methods, HPLC and UPLC.
The job
You will be responsible for development of analytical methods for the next generation of products for diabetes treatment. You will be part of one or more project groups within the analytical development team and refer to the team leader. Your main focus will be to develop analytical methods within UPLC and HPLC techniques in order to support development of drug substances and drug products. The analytical development discipline includes generation of relevant documentation, validation, robustness, stability, characterization support and regulatory documentation.
You will work in a series of diabetes projects in close cooperation with the Research Unit, Formulation Development, Upstream and Downstream API Process Development, Product Supply, Structural Characterization, Quality and Regulatory Affairs.
Together with your colleagues you will contribute to the on-going optimisation of processes and systems using LEAN.
Qualifications
You hold a Master’s degree within Life Sciences (Pharmacy, Engineering or other relevant discipline). A PhD or similar experience is an advantage but not a requirement. You have a minimum of 2 years of practical experience within HPLC/UPLC analytical development in the pharmaceutical industry. You have a good knowledge of general protein chemistry, HPLC/UPLC and validation. Knowledge of GMP/GLP regulatory requirements is an asset. Analytical development is based upon several tools, e.g. Design of Experiments and Mathematical Modelling. Therefore, knowledge hereof is an advantage.
As a person you have a positive and flexible mind-set, which is helpful in an ever changing project environment and enabling you to build fruitful relations to colleagues and stakeholders. You are a team player and contribute to reaching team goals. You have excellent English oral and written communication skills.
At Novo Nordisk, 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.
Contact
For further information, please contact David Nolan at +45 3075 6398 or Karoline Benktander at +45 3075 8013.
Deadline
28 June 2013.