Analytical Specialist – Product Lifecycle Management (PLM)
Orifarm Manufacturing Viminco is looking for an experienced pharmaceutical Analytical Chemist with the specialist knowledge and drive to help us realize our growth ambitions for the development and manufacture of new pharmaceutical products and optimisation of our existing product portfolio.
Who are you?
You are a graduate (e.g. pharmacist, Cand. Sci or similar) with a strong academic and professional background in analytical chemistry and chromatographic methods (primarily HPLC), and have experience with developing analytical methods in these areas. You have a minimum of 3 years of experience as an analytical chemist with special focus on HPLC. Experience in the pharmaceutical industry is a strong plus. Experience preparing CMC documentation for registration applications to pharmaceutical regulatory authorities is highly beneficial, as is knowledge of analytical techniques for tablet dosage forms e.g. dissolution testing.
As a person, you are enthusiastic, careful, structured, flexible, development-oriented and eager to learn. You have the desire and ability to keep many balls in the air and are adaptable when needed. You are ready to take responsibility, to think and work independently and as part of a cross-functional team. You have strong cooperative skills which will be instrumental in maintaining the good atmosphere within the PLM Team / Development Department and help to ensure a positive collaboration with colleagues in QC and other business functions.
What are you going to work with?
- Development and optimization of analytical methods in connection with Product Lifecycle Management
- Troubleshooting on complex analytical issues
- Participation in project teams as primary analytical representative
- Preparation of analytical validation protocols, reports and evaluation of data
- Preparation of CMC (“quality”) documentation for variation applications
- Analysis of samples to support product lifecycle studies in collaboration with our technicians
- Analytical method transfer to our commercial QC laboratory or external partner laboratories
- Evaluation of analytical methods and results from external laboratories
- Set up protocols for testing, data processing and reporting of test results
- Development and maintenance of an appropriate scientific knowledge base, particularly in relation to relevant analytical techniques
- Promoting and ensuring the correct application / interpretation of Ph. Eur and GMP
Who are we?
Orifarm Manufacturing Viminco (Orifarm MV), headquartered in Skælskør, Denmark, is part of the Orifarm Group, one of the Nordic region's largest pharmaceutical companies, and we develop and manufacture pharmaceutical products for Orifarm Generics’ portfolio and a number of well-consolidated companies in the Nordic region. We have experienced strong growth over the last few years and Orifarm's vision is to further strengthen our capabilities.
You will be part of a growing team responsible for diverse projects related to Product Lifecycle Management. This is a particularly exciting time for the team as we begin to explore opportunities for collaboration with new manufacturing sites recently acquired by Orifarm. The team sits on the interface of Development and Commercial Operations and is responsible for:
- Troubleshooting and optimization of existing products
- Facilitating technology transfer of products and test methods to commercial Operations team and across sites
- Transfer of newly acquired products into our facility
- Development studies related to out-licensing of existing products
By choosing a position in Orifarm MV, you will have the opportunity to help set the agenda and thus greatly influence your own daily life. We thrive in making idea to implementation, and decisions are made quickly. You will be part of a company where employees are the driving force.
If you have questions, please feel free to contact Chief Development Officer, Jonathan Castile (tel: 27804709) and also send your application through this job posting as soon as possible and no later than 30th September 2021. Applications will be evaluated on a continuous basis.
Ansøgningsfrist:30. september 2021