3D-PharmXchange is interested in high-level experts in all key drug development disciplines. Candidates should 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.
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 you will have freedom to shape your work.
3D-PharmXchange does not accept unsolicited resumes from any third-party recruiters or agencies. Acquisition is also not appreciated
Consultant non-clinical development
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.
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 Toxicology and/or ADME 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.
- 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 a motivation letter to Nina Lemmers-van Erp at email@example.com. For more information you can also contact her at +31 (0)13 53 482 72
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.
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.
- 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 firstname.lastname@example.org. For more information, you can also contact at +31 (0)13 5348272.