To strengthen the growth of OM Pharma, we are currently looking for a Head of Analytics & Cell Biology Development for our manufacturing plant in Geneva. In this function, you report to the Head of Product and Industrial Development and manage a team of approximately 15 people. Your role is to provide technical and strategic input to ensure high-quality execution of biochemical, chemical and cell-based potency assays; and to actively collaborate with other departments such as Quality Management, Manufacturing or Regulatory affairs in different strategic projects. Your main missions are:
- Manage the development of the teams in Analytical Chemistry, Biochemistry and Cell Biology: develop people, ensure reliability, meet deadlines, make decision in a timely manner, promote team cohesion and ownership, ensure operational effectiveness Closely manage budget of the team (OPEX, CAPEX, FTE): budget establishment, follow-up, accrual management, forecast
- Act as Project Manager or Projects member for technical and pipeline projects of the site
- Act as a leader in chemical, biochemical and cell-based potency assay development, validation, method transfer and samples analysis for technical projects activities
- Coordinate and lead activities to support the analytical arm of investigations, troubleshooting, Root Cause Analysis, deviations and CAPAs in collaboration with other departments
- Lead, develop and implement appropriate analytical technologies and methods to characterize products manufactured by OM Pharma
- Ensure optimization and evolution of existing methods to meet Quality requirements and Operational effectiveness of Quality Control
- Supervise staff, define development and analytical validation designs, review and approve validation protocol, study data and reports generated by the teams to ensure scientific validity and regulatory requirements
- Ensure analytical transfer of any new methods to Quality Control
- Identify and collaborate with external service providers and a network of relevant experts to support development
- Contribute to the preparation and revise documents in support of CMC regulatory filings and addressing queries related to analytics (development, validation, stability indicating properties, specifications definition, …)
- Manage inspections and audits for analytical development and validation activities
For this role, we are looking for a reliable, solution-oriented and business-driven experienced leader, bringing the following profile:
- University degree in Biological sciences such as cell biology, biochemistry, immunology or biotechnology (or similar)
- At least 10 years’ experience in Analytical Development and Validation within the pharmaceutical industry
- Extensive experience in analytical and cell based potency assay development, validation and samples processing
- Fundamental understanding of statistical analyses for analytical and bioanalytical assay development
- Proven experience in a GMP environment
- Strong experience in Line Management
- Fluent in French and English both in oral and written conversation.
Thanks to your communication skills, you easily develop new relationships and feel comfortable in a situation where you need to influence and convince other people. You want to take initiative to move things forward and to motivate people towards a common goal. You hold extensive people management experience and truly love to coach your teams and help them reaching success. Furthermore, your negotiation ability and strategic thinking enable you to examine and understand issues from multiple points of view and to easily influence others.
You are currently looking for a new challenge in a dynamic and agile company, where you can make the difference and leave your footprint.
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 companys 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