Location: Switzerland - Glattbrugg/Zurich
Function: Technical Operations
Company: Vifor Pharma
Our External Development team is growing and in this new position, we are seeking an External Development CMC Manager who will be responsible to ensure the development of line extensions and new drug product development with third party companies, according to management objectives and plans. Report to the Head of External Development CMC, your tasks and activities will include the following:
- Management of development projects; cooperation with and control of commissioned companies
- Collaboration with employees within project teams and in a cross-functional environment
- Ensure the implementation of laboratory work necessary for the development of new products, forms and processes
- Production of clinical trial samples according to the guidelines
- Determination of technical specifications of new products
- Cooperation in the development and validation of industrial manufacturing processes
- Ensure the creation of the technical documentation and manufacturing protocols required for registration
- Transfer of drug products to or between third party manufacturing sites
- Participation in technical production support, if necessary
- Ensure that the quality of the work carried out complies with the valid requirements for the registration of products and with GMP and ISO standards
- Regular information of supervisors concerning the progress of the projects and the occurring problems
The ideal candidate brings a Pharmacy degree, Analytical Chemistry degree or related higher education, in addition to the following skills and experience:
- Significant experience working within the pharmaceutical industry with a background in late-stage development and/or production
- Basic knowledge of technical operations, medical affairs and regulatory affairs
- Strong project management skills
- Fluency in English, language skills in German preferred
You are organised and able to manage multiple activities in parallel, within the scope of your objectives and making the most of available resources. You are able to work effectively in an autonomous manner. You have strong communication skills, orally and in writing, which enable you to collaborate effectively with internal and external stakeholders. You work in line with the Vifor Pharma values.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.