About PamGene
PamGene International B.V., is an in-vitro diagnostics and biomarker services company in ‘s-Hertogenbosch, The Netherlands. Pamgene is expanding its activities to further commercialize its IVD certified products IOpener®-Melanoma and IOpener®-Non-Small-Cell-Lung-Cancer (NSCLC).
Immunotherapy has revolutionized cancer treatment, but high costs, relatively low efficacy rates, and severe side effects are important challenges to improve its use. Predicting immunotherapy response is critical for fully realizing its potential in treating early-stage tumors and enhancing immunotherapy treatment regimens. PamGene’s IOpener® is a CE-IVD registered diagnostics testing platform for immunotherapy response prediction. The blood test can predict a patient’s response, before immunotherapy is started, from a simple blood draw. The IOpener® test platform aims to revolutionize the precision-medicine sector, enabling the widespread use of immunotherapy at any cancer stage.

About Iopener® – A liquid biopsy immunotherapy guidance test
The IOpener® is a blood-based diagnostic test that supports immunotherapy guidance for melanoma and non-small cell lung cancer (NSCLC) patients. The test measures baseline, before therapy starts, the kinase activity in peripheral blood mononuclear cells isolated from a single tube of blood from a patient to determine the likelihood of responding to immunotherapy. The IOpener®-NSCLC and the IOpener®-melanoma are CE-IVD registered devices that are developed and manufactured in PamGene’s ISO 13485:2016 certified facility. At present Pamgene expands commercial activities and clinical utility studies are started in key countries in Europe (Netherlands, Germany, France) to underpin health benefit of the IOpener for the patient whilst reducing cost use of immunotherapy.

Job description
PamGene is looking for a Program Manager IVD, based at our offices in ‘s-Hertogenbosch, The Netherlands. She/ he will work and collaborate across internal departments, as well as with external partners, to guide the company to IVD product expansion and IVDR registration and commercial IVD product launch in the Netherlands and Europe and to help improve cancer immunotherapy treatment. We are looking for a self-motivated, hands-on, and goal-oriented professional who is adept at working within a commercial and clinical R&D environment. The program manager is involved in project monitoring, setting up clinical studies in the field of medical oncology, as well as in commercial and strategic planning with external partners and budgeting initiatives. She/ he will also be involved in building up sample logistics and routine services with clinical labs in the project.

Job Responsibilities
• Daily management of the timelines, budget and deliverables of the IVD product development and clinical programs.
• Ensure that IVD-project team data, processes, activities, decisions, and changes are clearly communicated, documented, and archived, and acting as a primary contact for management.
• Contributes to building of the technical file and design history file of the IVD products, required to obtain CE-IVD registration.
• Work with the operational departments to ensure a smooth and seamless transition from product development to providing IVDR certified products and related services.
• 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.
Qualifications we seek for
• At least a M.Sc. degree (or equivalent) in (bio) medical sciences or life sciences, preferably demonstrating a background in the field of immunology, cell biology, and/or medical oncology.
• Thorough understanding of different stages of IVD & medical device development and market introduction. Strong project management skills with relevant experience in developing medical devices or IVDs
• Good technical understanding and the ability to work with internal and external teams of scientists and engineers.
• Experience with the ISO13485 quality management system and IVD regulations.
• Excellent communication/interpersonal skills and being able to communicate complex issues both orally and in written form for various stakeholders.
• Good sense of humour and ability to adapt to a changing environment as the company matures and moves from the R&D stage to the commercialisation of IVD products and services.
Other, desirable qualifications
• Knowledge of global IVD device registration authorities, CLIA service laboratories and/or experience in working with Notified Bodies is desired.
• Experience with biomarker development providing IVD products and/or services.
• Awareness of implementation of the In-Vitro Diagnostic Device Regulation (IVDR) in the EU.
• Leadership experience.

What we offer
• An exciting and new position within a growing and innovative company.
• An informal and international operating work environment.
• Good salary package including pension and travel allowance
• Ability for career development and self-developing.

Contact details
For more information on the job, please contact John Groten (jgroten@pamgene.com) or Rinie van Beuningen (rvbeuningen@pamgene.com) and our website at www.pamgene.com. Applicants should send their curriculum vitae with a covering letter (including a brief description of experience) to Piek Wei Ong, Office Manager at PamGene (pwong@pamgene.com).

What Does PamGene Do?
PamGene International B.V. is a Dutch biotechnology company based in Den Bosch.
We have developed a unique technology that provides researchers and physicians with insights into the signal transduction processes that occur within our bodies. In addition to many applications in research, such as oncology and metabolic diseases, our product recently gained a diagnostic application. With this, we can predict which treatment is most likely to align with a patient’s treatment plan. Would you like to contribute to building our amazing company and help produce these high-quality products? If so, read on!

What Will You Do?
As a Cleanroom Technician at PamGene, no two days are the same.
The production process of our PamChips involves numerous steps, each with its own quality controls. You will be involved in every step of the process and play a vital role within the organization. Your contribution is essential to the quality and consistency of our products. Because we will train you across a broad range of tasks, your biotechnological knowledge will expand significantly. You will also learn to work with various machines and robots.

PamGene is ISO 13485:2016 certified, and we work with standardized procedures and work instructions. In your new work environment, you will receive direct guidance from experienced colleagues and supervisors. Whether you are just starting out or are more experienced, there is a lot to learn.

What Do We Offer?
PamGene is located in the heart of Den Bosch’s charming city center and is easily accessible by public transport. During breaks, you can take a walk, grab a tasty sandwich, or quickly run an errand.

At PamGene, you’ll work closely with your team and also have frequent contact with other departments. Our company consists of approximately 30 colleagues. Communication is informal and direct; you can easily approach anyone at all levels. PamGene offers a competitive salary that is based on your knowledge and experience, with room to accommodate your personal development goals.

Do You Have These Qualities?
– You have completed an MBO4/HBO education (e.g., process technology, biomedical sciences, chemical-physical studies);
– You are accurate and a motivated team player who enjoys a challenge;
– You have a keen eye for detecting deviations in the process and product;
– You enjoy working in a cleanroom;
– You value quality;
– You have a good command of Dutch and/or English;
– You are familiar with Microsoft Office.

Interested?
Send your CV and motivation letter to:
Piek Wei Ong – Office Manager
Telephone: +31 (0)73 615 8935
Email: pwong@pamgene.com

PamGene International B.V.
Wolvenhoek 10, 5211 HH ’s-Hertogenbosch, The Netherlands
www.pamgene.com