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Stillingstittel: Research Scientist/Principal CMC professional

Stillingsbeskrivelse:
Curida is an international Pharmaceutical industry, based in the heart of Elverum, Norway. The company has core competency in state-of-the-art manufacturing of Liquid Pharmaceuticals and Nutritional Supplements. The development expertise covers the full service for the development of nasal drug products and a wide range of laboratory- and raw material services. We operate in the international market with export to more than 90 countries worldwide. The company was established in 2015 and is growing rapidly supported by solid owners. Curida is part of an exciting and growing life science sector in Norway, and our vision is to be the National Centre for Industrialization of Medical Innovation. Curida is an active partner and member of Oslo Cancer Cluster.

Curida AS is a Contract Development and Manufacturing Organization (CDMO) within the Pharmaceutical Industry. Our development projects have been rapidly growing since the company start-up in 2015. We are now looking to strengthen the Development Department with a Research Scientist / Principal CMC professional, who will have a central role in the CMC's professional implementation of development projects, with primary focus on generic drug products. We are looking for you who have experience within pharmaceutical development and know what it takes of documentation to get the drug product in the market. We offer an exiting position in a dynamic environment where you will be part of the journey of a rapidly growing company.

Key responsibilities and work tasks:
- Professional responsibility for CMC in the product and process development of generic and novel pharmaceuticals in development projects, typically including:
* Leading the formulation experiments
* Defining critical product and process parameters of the control strategy
* Support analytical method development and validation
* Establishment of manufacturing process
* Leading the manufacturing process development from lab- and pilot- to full scale, including process validation and the preparation of documentation
* Design of ICH stability studies
* Preparation of the relevant CMC registration documentation required for Pharmaceuticals

- Project Management of internal pharmaceutical development projects, and externally towards customers
- Business activities towards international customers and partners
- Professional resource within Pharmaceuticals Development, solution-oriented contributor in situations which require special attention.
- Support and partner with the Production- and Sales Departments.

Qualifications:
- Master's degree in Pharmacy or Chemistry
- Experience from the Pharmaceutical industry, with a preference from drug development according to GMP and/or GLP.
- Knowledge of regulations regarding the development and manufacturing of Pharmaceuticals (GMP, ICH guidelines, relevant legislations and guidelines), including ISO 13485
- Advantage, but not a requirement; experience from development of liquid drugs, such as eye drops, nasal drops and -spray, suspensions and injection preparations.
- English fluently, and good skills in Norwegian

Personal characteristics:
We are looking for a proactive person with a genuine interest in drug development. In addition:
- Enjoy working on projects, with the ability to keep the overview and at the same time work systematically, independently, accurately and efficiently.
- You are solution oriented, hold a drive force and are known for completion of work tasks.
- Enjoy working in a GMP regulated environment and set high demands on your own and others' efforts.
- Independent, but also a team player.
- You identify with our values: flexible, enthusiastic, trustworthy and courageous.

We offer competitive terms in a high competence international environment. Workplace is Oslo, and at our manufacturing site in Elverum. Our Oslo premises are located at Oslo Cancer Cluster. With international customers, travels will be required.

Application
Application and CV marked with "Development" to be sent to HR (at) curida.no. Applications will be processed on an ongoing basis.
For further details, contact Head of Development Torunn Heyeraas +47 473 47 600 or CEO Leif Rune Skymoen + 47 996 49 419.

Vi vill inte bli kontaktade av rekryterings-/bemanningsföretag.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2131

abstractJV_contact_0:
Link to the vacancy on the Swedish job board

requiredEducationLevelCode: 0

requiredYearsOfExperience: 0

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbeidsgiver Navn: Veksthuset Rekruttering AS

source: PES-SWEDEN