3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm with offices in Tilburg and Oss. They are a dedicated team of Drug Development experts covering the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, they provide out-licensing and interim management support. Their clients are mainly early phase biotech, but they also support leading big pharma companies.
The CMC team, specialized in delivering CMC support to pharmaceutical companies and biotech industry, are 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
- 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.
For more information, please contact: