Consultant CMC

Company Profile
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm with offices in Tilburg and Oss. We are a dedicated team of Drug Development experts covering the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide outlicensing and interim management support. Our clients are mainly early phase biotech, but we also support leading big pharma companies.

Job description
Our CMC team, specialized in delivering CMC support to pharmaceutical companies and biotech industry, is seeking to expand with an enthusiastic colleague. Depending on the customer project you may be working on any aspect of CMC development for a biological (including ATMP) or small molecule; both in a managing role, and as a Subject Matter Expert. Thus, your experiences in early
and late stage process development, including formulation development, analytical assay or
method development, CMC regulatory trajectories, manufacturing of Drug Substance/API or Drug Product, Technology Transfers, and selection and management of CROs and CMOs are all key assets for this role. Reviewing development and validation protocols and reports, and writing documents for regulatory purposes, is part of the role.

PhD (preferred) or MSc in the area of Bio (process) technology, Chemistry, Analytical Chemistry, Pharmaceutical Sciences. Demonstrated competency, experience, and knowledge in CMC development and manufacturing requirements from early to late phase within the pharmaceutical industry. At least 5 years of experience in a comparable position and/or work environment is required.

Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, organizational sensitivity, stakeholder management. Essential communication skills: fluency in English, oral, writing and presentation skills. Specific hands-on experience in one or multiple of the following focus areas is desired: upstream processing of Biologicals (fermentation; cell culture); process chemistry, analytical assay or method development.

Demonstrated competency in writing and reviewing the CMC regulatory submission documentation (IND/IMPD/NDA/BLA) and answering any possible CMC regulatory questions. Network in (local) biotech industry. Thorough experience in project management and project teamparticipation. Experience with CRO and/ or CDMO selection and management is desired.

Interested? Send your CV and a motivation letter to Nina Lemmers-van Erp at For more information, you can also contact at +31 (0)135348272.
Acquisition is not appreciated

Pivot Park Captains' Dinner

10 years ago, Pivot Park opened its doors to the world. Thanks to your commitment, support and confidence, we have been able to grow it into the successful and innovative biopharmaceutical campus it is today.

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Erwin Wurm | Am I a House?

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The development of medicines in Oss began one hundred years ago. It was then that the foundations were laid for what would become a flourishing pharmaceutical sector in the Netherlands, leading to groundbreaking discoveries such as insulin and the anti-conception pill.

Today, the entire chain is still represented in Oss, from early-stage research to the commercial scale production of medicines. Working in Oss, we focus on the health of people all over the world. Employees at dozens of companies large and small put their heart and soul into new medicines, products and services that will improve lives worldwide. Together, our strength lies in our combination of broad knowledge about the development of medicines and a thorough understanding of the requirements of high-quality production.

This shared past and common values stimulate strong bonds among everyone who works in pharmaceuticals in Oss. We build on qualities, expertise and networks that go back decades. And with a wide variety of pharmaceutical companies, suppliers and scientific institutions all located nearby, we offer an attractive business climate and an excellent basis for international collaboration.

We are proud to work together to create a better and healthier future for all, a collaboration that in turn fuels growing employment: today, most pharmaceutical jobs in the Netherlands are in Oss. Here we connect talent and companies and stimulate entrepreneurship, while our expert employees are our most important asset. Their drive ensures that Oss has an influence on health all over the world.

Pharma in Oss offers endless opportunities to startups and talent in a city and region that is a joy to live and work in. We are committed to collaboration and sustainable and successful entrepreneurship. Oss’s pharmaceutical companies are intrinsically competitive while also being committed to quality and safety. This, plus their focus on new health solutions and contemporary technology, makes us a leader in our pursuit of a better life for people worldwide.