Companion Diagnostics

GenDx is considered as the expert in transplant diagnostics. One important aspect therein is to provide high-resolution HLA typing to facilitate better matching of patients and donors and hence a better outcome of transplantation. GenDx is entering a new field, in which we are engaged with several pharma companies who are developing T-cell therapies.

Within the field of oncology, there is an increase in the use of a new type of therapy, in which patients are treated with modified immune cells (T-cell therapy). These T-cell therapies can be performed with the patient’s own T-cells, or with those of an unrelated donor.

It is common practice to determine the HLA type of the patient to determine if the patient can be treated with this kind of therapy.

For this challenge, we are hiring colleagues to help cancer patients get the best possible treatment.

• PROJECT COORDINATOR
• REGULATORY / TECHNICAL WRITER

PROJECT COORDINATOR

Responsibilities
▪ Overall direction, coordination, and monitoring of a Companion Diagnostics Project.
▪ Ensuring consistency with project/company strategy, commitments.

REGULATORY / TECHNICAL WRITER

Responsibilities
▪ Involved in the development of Companion Diagnostics, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to applicable authorities.
▪ Process scientific documents from initiation to completion, in accordance with guidelines and requirements of regulatory authorities.

PROJECT COORDINATOR

• PhD in molecular biology, or equivalent.
• Experienced in translation of technological advances into new products and customer benefits.
• Highly experienced with quantitative real-time PCR, DNA sequencing, and related analysis software.
• Advanced project management and presentation skills.
• Outstanding in keeping overview with eye for detail.
• Strong communication skills.
• Strong organization and collaboration skills.
• Preferably, experience with working in a (scientific) company, where work is done according to ISO 13485.
• Excellent command of Dutch and English (written and spoken).
• You live in the Utrecht Science Park area, or are willing to relocate.

REGULATORY / TECHNICAL WRITER

• PhD in molecular biology, or equivalent.
• Knowledge of and proven professional experience with relevant territorial regulatory requirements, such as the IVDR and MDSAP.
• Preferably, experience with working in a (scientific) company, where work is done according to ISO 13485.
• Strong writing and communication skills.
• Outstanding in keeping overview with attention to detail.
• Experienced with working on own initiative, as well as with being part of a team.
• Excellent command of Dutch and English (written and spoken).
• You live in the Utrecht Science Park area, or are willing to relocate.

What’s on offer?
Becoming part of a driven, ambitious team, within an international working environment.
Employment based on a 40 hour work week, and working from home one day per work week.
Further, GenDx offers a competitive salary, pension scheme, 31 holidays (including 6 collective leave days), laptop, ample opportunity for personal development and a membership at Sports Center Olympos.