PamGene International B.V.
PamGene is a Dutch biotechnology company founded in 2000 and with headquarters in Den Bosch, NL. The company offers research services with a unique and proprietary microarray platform for functional proteomics activity profiling and cell signaling analysis. PamGene develops therapy response prediction biomarkers for candidate drugs and other active ingredients as well as diagnostic applications for a number of immuno-oncological targets. PamGene’s microarray technology is used in a broad range of applications in pharmaceutical research and in (pre)clinical development to gain insights into disease development and basic research. The company consists of 31 employees.
Program Manager In Vitro Diagnostics
PamGene is looking to recruit a Program Manager IVD, who will work collaboratively across internal departments as well as with external partners, healthcare providers and regulators and other stakeholders to help guide the company to its first IVD product launch based on in-house phospho signalling platform developed for cancer treatment.
We are looking for a self-motivated, hands-on and goal-oriented individual who is comfortable of working within a small, dedicated team in SME environment. Program manager is responsible for project monitoring, technical dossier and involved in strategic planning and budgeting initiatives.
- An individual with a strong background in diagnostic field and at least a M.Sc. degree or equivalent in life science discipline e.g. in (medical) biology or clinical oncology.
- Thorough understanding of different stages of IVD & medical device development and market introduction.
- A strong technical understanding and hands-on project management experience in developing medical devices or IVDs and a proven ability to work with internal and external teams of scientists and engineers to accomplish product development goals.
- Excellent communication/IT skills and being able to communicate complex issues both orally and in written form in a simple way for various stakeholders.
- Working knowledge and thorough understanding of the principles of immunology, oncology and genomic and/or proteomic multiplex array testing platforms.
- Good sense of humour and ability to adapt to a changing environment as the company matures and moves from the R&D stage into IVD services commercialisation stage.
- Attention to detail and an enthusiastic, inquisitive, hard-working attitude.
- Knowledge of EMA, FDA or other global IVD device registration authorities, CLIA service laboratories and interaction with Notified Bodies is desired.
- Experience with providing diagnostic services, ISO13485 quality management and preparation of the Technical File. Also awarenes of implementation of the new In-Vitro Diagnostic Device Regulation (EU) 2017/746 is desired.
- Daily management of the IVD product development and clinical validation to ensure that the IVD product meets the intended use within the given timelines and budget.
- Ensure IVD-project team data, processes, activities, decisions, and changes are clearly communicated, documented and archived and acting as a primary contact for management.
- Responsible for managing the technical file/design dossier and quality management systems required submissions to regulatory authorities to obtain CE-IVD registration.
- Work with the bioassay and biochip operational teams to ensure a smooth and seamless transition from R&D to launching an IVD-service testing platform.
- Engaging and proactively communicating with key internal stakeholders and present the IVD-service testing platform and its technology to academic, government and payers at congresses and meetings.
PhD Student position
We invite applications for a three-year Early Stage Researcher (Ph.D. student) position on phospho-signalling of the retina to assess early biomarkers for neurodegenerative diseases and cell toxicity. The position is part of the Marie Sklodowska Curie Initial Training Network transMed.
We welcome your Applications, please follow or download the link for details on where and how to apply: