Associate Director (m/w) IVD Product Development
The Associate Director IVD Product Development will take a leading role in IVD development projects for Sysmex-Inostics OncoBEAM products in cancer diagnostics. The focus will be on development of the assay reagents and workflow procedures for the Sysmex-Inostics new IVD products. The Associate Director (m/w) IVD Product Development will represent R&D within cross functional project teams.
Education, Professional experience
- Product development lead for new IVD molecular diagnostic assays throughout all product development phases from Feasibility through Clinical phase.
- Technical lead for a team of scientists and laboratory assistants in the IVD Product Development department.
- Planning and management of R&D-tasks (scope, experiment design, timelines, budget/ resources) within IVD-product development projects
- Represent IVD Product Development in cross functional teams
- Communication and coordination with internal and external project members and stakeholders, including project management, regulatory affairs, quality management, marketing, external cooperation partners, suppliers, customers
- Lifecycle management support for investigations and design changes to support products post-launch
- Contribution to department ‘s responsibilities, like resource, expertise and budget planning, definition and improvement of processes, definition of product development and technology strategy
- Ph.D. in biology or biotechnology
- 5+ years of experience in the molecular in vitro diagnostic industry in assay development under Design Control, including prior management of assay development team
- Proven record in development of IVD molecular assays which resulted in CEIVD marking and/ or FDA clearance
- Experience in development of PCR-based assays or other amplification technologies
- Prior experience in flow cytometry technology is desirable
- Prior experience in cancer diagnostics is a plus
- Very good knowledge of quality management of regulatory requirements (ISO9001/13485, 21 CFR 820.30) in development of IVDs in Europe and/ or US
- Excellent communication and teamwork skills in interdisciplinary and international teams.
- Ability to work in a dynamic environment with tight timelines
- Structured and results focused working style.
- Fluent English, knowledge of German is desired
We look forward to receiving your application. Please tell us your salary expectations and earliest possible starting date.
Please apply online via email email@example.com with the reference number 16-11.
While applying for the job please refer to jobvector and use the following reference number: 16-11
Frau Janine Kling
Please apply online - firstname.lastname@example.org - with the reference number 16-11.
About Sysmex Inostics GmbH
Als Teil der Sysmex-Group sind wir ein international agierendes Unternehmen im Bereich der Molekulardiagnostik. Unsere Kernkompetenz liegt in der Analyse genetischer Veränderungen wie zum Beispiel Mutationen in Blut- oder Gewebeproben von Krebspatienten. Wir unterstützen internationale Pharmaunternehmen bei der Entwicklung von IVD Companion Diagnostics sowie der Analyse von...More about Sysmex Inostics GmbH