Location: Switzerland - Meyrin/Geneva
Function: Research and Development
Company: Vifor Pharma
Attached to the pharmaceutical development department your activities are related to all the tasks leading to the pharmaceutical development and ensuring the life cycle management of a drug. For this challenging role at our site in Meyrin/Geneva, we are looking for an experienced Pharmaceutical Development Specialist with the following responsibilities:
- Ensure the development and if needed the transfer on other sites (affiliate / partners).of the OM Pharma / Vifor Pharma products
- Conducts laboratory tests as part of pharmaceutical development
- Provide the elements necessary for the preparation or modification (variation) of the technical part of the Common Technical Document (CTD)
- Support the production department for all activities or questions related to formulation and/or manufacturing process
- Acts as team member in technical project according to the practices in place
- Identify and select the materials needed for the production of formulations in the laboratory, pilot and industrial scale
- Select the pharmaco-technical methods and check its ability to document the trial
- Plan and perform manufacturing trials in collaboration with the concerned departments
- Write the manufacturing protocols in collaboration with the production department
- Write the transfer report useful to support submission to health authorities (variation, modification or new CTD)
- Support RA regarding technical questions about production or transfer of industrial product
- Review all technical document linked to a production or transfer process
- Identify and select the materials needed for the production of validation/stability batches
- Manage the indicative stability studies and centralize the resulting data according to the established schedule
- Identify and select raw materials (incl. Suppliers) compatible with the product to be manufactured
- Integrate the approach of alternative suppliers
- Identify and select the equipment (incl. Suppliers) adapted with the product to be manufactured
For this role we are looking for a person with the following profile:
- University degree in pharmaceutical sciences
- More than 3 years of experience in Pharma Dev. laboratory within a pharmaceutical industry
- Good experience in pharma production and/or product transfer
- Experience in pharmaco-technical characterization
- Previous experience in product development and/or line extension
- Ability to identify and approach suppliers and maintain the relationship
- Good knowledge of GXP standards and technical parts of CTD
- Experience with creating reports or technical document writing / CTD writing (an asset)
- Mother tongue French, fluent in English, knowledge in German is an asset
- Comfortable with the use of MS Office, control software (Viscosity,
- Data logger, Laser, Lyo, etc.)
We are looking for a methodical and organized person for this position.
Furthermore, you should demonstrate a strong internal and external customer orientation. Being in that role will allow you to underline your “can do” attitude, team player spirit and act as a role model for others in line with OM / 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.