Posted: 5 January 2022

Director Chemistry, Manufacturing and Control – 3D-PharmXchange

Location: Tilburg, The Netherlands
Hours: 40

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 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 innovative biotech start-ups as well as leading big pharma companies.

Job description

Our CMC team, specialized in delivering CMC support to pharmaceutical companies and the biotech industry, is seeking to expand with a Director CMC that will lead our team of CMC experts, and work as a consultant on customer programs. 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, may all be part of the role.

The Director CMC will lead a team of 5-10 consultants in the CMC area, including coaching (especially the more junior) consultants in their roles in customer programs as well as a target setting for the individual reports and appraisal of the consultants. The Director CMC has responsibility for the sales target for the CMC team and support in business development will be part of your role. The Director CMC will be part of the extended management team within 3D-PharmXchange.

Requirements and qualifications

  • 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 phases within the pharmaceutical industry.
  • At least 5 years of experience in a comparable position and/or work environment is required.
  • People management experience is required
  • Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality, organizational sensitivity, stakeholder management, people 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: process chemistry, formulation development; upstream processing (of Biologicals – fermentation; cell culture); analytical assay or method development.
  • Demonstrated competency in writing and reviewing CMC regulatory submission documentation (IND/IMPD/NDA/BLA) and answering any possible CMC regulatory questions.
  • Network in the (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 about this vacancy, contact Managing Partner Albert Peters +31 6 28209882

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