Formulation Development Specialist – Product Lifecycle Management (PLM)
Orifarm Manufacturing Viminco is looking for an experienced Formulation Development Specialist with the 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, chemist, engineer) at masters level or higher, with a strong academic and professional background in pharmaceutical formulation development, and have experience with the development of solid dosage forms under GMP conditions. The ability to handle, interpret and report scientific results is a key requirement. You bring a minimum of 3 years of experience in the pharmaceutical industry. Experience preparing CMC documentation for registration applications to pharmaceutical regulatory authorities is highly beneficial.
As a person, you are enthusiastic, careful, structured, flexible and development-oriented with an eye for GMP. You have the desire and ability work on multiple projects and are ready to take responsibility. You can 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 in the PLM Team / Development Department and help to ensure a positive collaboration with colleagues in Production and other business functions.
What are you going to work with?
- Optimization of pharmaceutical formulations and processes for existing products
- Troubleshooting in production in collaboration with Production Support
- Technology transfer of products to/from Orifarm MV from/to other manufacturing sites
- Technology transfer of products from Development to Commercial Operations
- Evaluation and implementation of API and excipient changes / addition of second supplier
- Participation in project teams as primary formulation development representative
- Preparation of process validation protocols, reports and evaluation of data
- Preparation of CMC (“quality”) documentation for variation applications
- Development and maintenance of an appropriate scientific knowledge base
- Promoting and ensuring the correct application / interpretation of GMP
Who are we?
Orifarm Manufacturing Viminco (Orifarm MV), located 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 newly established 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