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.
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 firstname.lastname@example.org. For more information, you can also contact at +31 (0)135348272.
Acquisition is not appreciated