Careers At 3D

No drug is developed by a single person. We understand that it takes teamwork, perseverance to realize something this big. The 3D team works hard with room to laugh and is looking to expand.

If you are interested in 3D-PharmXchange, we invite you to contact us. You are always welcome to visit one of our offices for a coffee and discussion regarding our opportunities.

A Great Team & Atmosphere

At 3D-PharmXchange, you work with an experienced and dedicated team of professionals. Serious business with an informal way of working and room for a few laughs.

We offer a challenging job in an international environment, working for top entrepreneurs and big pharma. You will be working in a very dynamic, young, and growing team and have the freedom to shape your work. Although 3D-PharmXchange is well-known as an experienced partner in drug development, this doesn’t mean it is all about business. Our main aim is to centralize and empower our consultants. Not only professionally but also informally.

We Are Currently Looking For

Join our team of Dedicated Drug Development experts today.

3D-PharmXchange is interested in high-level experts in all key drug development disciplines. Our colleagues have an extensive and proven track record within companies developing innovative drugs (small molecules/biologicals/novel therapies), with a focus on early-stage drug development.

Below you will find our current positions and be reminded that we also appreciate open solicitations and are always eager to discuss future collaboration.

Vacancy : Consultant Non-Clinical Development

Company profile
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of (bio-)pharmaceuticals and diagnostics.
Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.

Job description
For the various projects that we are running for our clients, we are looking for a consultant non- clinical development to join our team of consultants. The ideal candidate has a background in ADME
(preferred) and Toxicology and is able to look beyond his or her borders and has an ambition to grow in a young and growing organization. Training and/or coaching will be provided in specific
areas if needed.

Minimal requirements

PhD or equivalent, or MSc degree in Life Sciences, with experience in drug development or
similar field
At least 3 years of experience as an ADME study director, non-clinical project manager or
other drug development role
Communication skills: good oral, writing and presentation skills
Personality skills: pro-active, team player, results-oriented, can-do mentality and ability to put
yourself in the position of our clients
Experience in a number of the following areas and roles (not all required):
Experience in conducting or monitoring drug metabolism studies
Experience in designing, monitoring or conducting safety (toxicology) studies at CRO’s and
analyzing/presenting data
Knowledge of and experience in global regulatory requirements for the development and
registration of new medicinal products (chemical entities and/or biologicals)
Experience in drafting and reviewing biocompatibility and/or safety assessments,
researching literature and toxicology database resources, and summarizing information
Experience in writing and/or reviewing documents for specific global regulatory purposes,
e.g. investigators’ brochures, IMPD, (non-)clinical dossier (eCTD), etc.
Understanding of Good Laboratory Practice (GLP) regulations
Project coordination and project team participation

Interested?

Send your CV and short motivation letter to Nina Lemmers-van Erp at nina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72

Vacancy : Consultant CMC

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. Writing development protocols and reports, and documents for regulatory purposes, is
part of the role.

Requirements

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 team participation.
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 nina@3d-pxc.com. For more information, you can also contact at +31 (0)13 5348272.

Acquisition is not appreciated