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. Next to the open positions, be reminded that we also appreciate open applications and are always eager to discuss future collaboration.
Vacancy : Consultant Regulatory Affairs
Company profile
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and the Pivot Park in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts aims to cover 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 development of the various projects we run for our clients, we are looking for a regulatory affairs expert to join our team of regulatory affairs consultants. The ideal candidate is able to look beyond his or her borders and has an ambition to grow in a young and growing organization. Coaching will be provided in specific areas if needed.
Minimal requirements
- Master degree in Life Sciences, e.g. Biomedical Sciences, Medical Biology, Pharmacy, Chemistry
- At least 3 years of experience in a regulatory affairs role
- Communication skills: good oral, writing and presentation skills
- Personality skills: pro-active, team player, entrepreneurial, can work under time pressure, 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):
- Knowledge of and experience in global regulatory requirements for the development and registration of new medicinal products (chemical entities and biologicals)
- Experience in preparation and submission of clinical trial applications
- Experience in preparing regulatory strategies for all stages of drug development
- Experience in writing and/or reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, nonclinical and clinical dossier (eCTD) overviews/summaries, DSURs/PSURs, pre-IND/End-of-Phase 2/scientific advice briefing/background packages, target product profiles, product information/labeling documents, risk management plans (RMPs), agency response documents, etc. .
- Experience in preparation and submission of scientific advice and orphan designation applications and pediatric investigational plans (PIPs)
- Experience in companion diagnostic regulations
- Experience with additional Risk Minimization Measures
- Experience in interactions and meetings with regulatory agencies
- Project coordination and project team participation
- Demonstrated competency and experience in all stages of drug development within the pharmaceutical industry
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
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 out-licensing 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.
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 her at +31 (0)13 5348272.
Interested?
Contact us by adding your information and resume and we will be in touch shortly.
