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Product Developer

Essange Reagents is seeking an experienced and highly motivated Product Developer to lead the development of new assays for Free Light Chains for the In-Vitro Diagnostic (IVD) market and support design changes in the exciting assays. This role will be pivotal in designing, developing, and optimizing assays that enable the detection and quantification of Free Light Chains in clinical samples, a key biomarker for diagnosing and monitoring diseases like multiple myeloma and other plasma cell dyscrasias. If you’re interested, read on for more details about the position.

Product Developer

• PhD
• 32-36 hours
• Location: Amsterdam
• min. €3.713 - max. €5.402

Job Description

As a Product Developer, you will collaborate with our Product Development, Regulatory Affairs, Production, and Quality teams to ensure the final product meets all regulatory requirements and is successfully registered in Europe and US. The primary focus will be on product improvement for free light chains used across various clinical analysers. You will be responsible for creating analytical performance plans and reports, as well as providing guidance on all related studies. Additionally, you will oversee the progression of the product across multiple platforms.

Your profile

• You finished your PhD training in Medical Biology, Immunology or Biochemistry;
• You have at least 5 years’ experience in assay development, clinical diagnostics, or a related field;
• You have a strong foundational understanding of light chain immunoglobulins;
• You are a seasoned project manager with a proven track record of success;
• You are a team player who enjoys collaborating closely with technicians, engineers, designers, and stakeholders;
• In-Vitro Diagnostic Directive / In-Vitro Diagnostic Regulations (IVDR) knowledge is crucial, especially for regulatory compliance;
• You have strong written and verbal communication skills to communicate technical information clearly to both technical and non-technical stakeholders;

What do we offer

We are offering a position in an extremely aspirational IVD company.

• a challeging position in a small team;
• an option to grow to position of head of Product Development;
• salary depending on education and experience between €3.713 and €5.402 gross per month;
• working hours are determined by mutual agreement (full-time is 36 hours)
• 8,33% year-end bonus;
• 8,33% vacation allowance;
• In case of full-time employment at least 201 vacation hours;
• a multiple-choice system in which your own terms of employment can be put together;
• various training and development opportunities;

About Essange Reagents

Essange Reagents is a spin-off of Sanquin that became an independent company in October 2022. We develop, produce, and market reagents and kits worldwide. Our offerings include blood grouping reagents and equipment, assays to replace pyrogen testing in rabbits (such as the monocyte activation test), a wide range of monoclonal antibodies, and semi-finished reagents produced under contract for the largest IVD companies globally. The Essange team consists of approximately 110 people, with about 20 working in Product Development.

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Opleiding:
Doctoraal / PhD

Specialiteit:
Biochemie
,
Biologisch medisch
,
Immunologie
,
Onderzoeker

Aanstelling:
Nader overeen te komen / 32-36 uur

Salaris:
min. €3.713 - max. €5.402

Plaatsingsdatum:
4 februari 2025

Sluitingsdatum:
7 april 2025

Locatie:
Amsterdam (Noord-Holland), Nederland

Essange Reagents

Adres
Plesmanlaan 125, 1066 CX Amsterdam
Standplaats
Plesmanlaan 125, 1066 CX Amsterdam
meer...

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