Product Development Manager

for a dynamic Biotech (diagnostics) company

Motivated, hands on manager who will development high-tech in-vitro diagnostic products together with a small team of strongly devoted experts.

Company

Our customer is a very successful Biotech Organization that develops high-tech diagnostic products and services using microarray technology.

The company was founded by a team of leading scientists and experienced business directors, won many business awards, and famous top executives reflected their confidence in the company by accepting a position in the supervisory board.

Position

The company has recently registered it’s first in vitro diagnostic product for AML molecular sub-typing onto the European market. The Pre-Market Approval preparations including a prospective clinical trial for the US market are progressing well. Currently, the company is in an advanced phase of translating several new in vitro diagnostics products from scientific phase into a product for clinical use. The quality system is based on GMP, ISO-13485 and ISO-15189.

During IVD product development, implementation, analytical studies for verification as well as clinical validation will demonstrate the capabilities and the quality of the product after which the product will be transformed into a deliverable product for third parties. This is a complex, challenging and very versatile task, and will be planned, performed and led by a Product Development Manager.

We like to get in contact with candidates for this position.

Candidate profile

The ideal candidate has experience with IVD product development. He/She has the scientific background as well as regulatory and quality knowledge to closely interact with the QA department, IT specialists and lab management and the experience to oversee what is required to bring the products to the market in compliance with the regulatory requirements.

A hands-on mentality is absolutely required. The Product Development Manager must be able to manage the team, is responsible for the project planning and meeting the product and project objectives accordingly and reporting progress to the management team in a clear and structured way according to the company’s procedures. He/She will make sure the product design and development process is performed according to the companies procedures and the product is suitable for it’s intended use. The candidate will contribute in improving the quality system to improve the product development process.

The candidate has excellent communication skills in Dutch and English, is experienced in the IVD or pharmaceutical product development. The candidate is experienced in product development under at least one of the mentioned quality systems.

The candidate should have a PhD in Molecular Biology, Analytical Chemistry, Biotechnology, Bioinformatics or comparable.

Preferences

It is strongly preferred if the candidate has experience in managing and contributing to IVD product development in which advanced IT systems take a prominent place. (e.g. in-house developed high-end analytical software and implementation of secure remote analysis)

Package

This role and position is ideal for a dynamic and versatile Product Development Manager. The company is young, successful and rapidly growing, and provides many opportunities for further career development. An IVD product development based on micro arrays on this scale is a unique opportunity.

Contact

Interested? For other information phone Key People who help us to fullfil this vacancy via +31 (0)348 401438. You can also apply by email:hr@skyline-diagnostics.com