Consultant CMC

Company profile

3D-PharmXchange is a drug development consultancy company located in Tilburg, Oss and Amsterdam. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and long-lasting relationships. Our team of experts cover the key areas in drug development of non-clinical, clinical, CMC and regulatory affairs. In addition, we provide project leadership and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups and academia. Our mission is to provide true patient-centered smart expert guidance to support the development of safe and efficacious drugs at the highest quality, highest efficiency and lowest costs.

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 small molecule; both in a (project) managing role, and as a Subject Matter Expert. Your expertise in early and late-stage process development, including formulation, chemical, and analytical development, is essential for this role. Experience with GMP manufacturing of API and/or Drug Product, Technology Transfers, and CDMO management is appreciated. The role involves reviewing development and validation protocols and reports. Additionally, experience with (co-) writing of regulatory documents is an advantage.

Requirements

• PhD (preferred) or MSc in the area of Pharmaceutical Sciences, Synthetic Chemistry and/or Analytical Chemistry.
• Demonstrated competency, experience, and knowledge in CMC development and manufacturing requirements from early to late phase within the pharmaceutical industry.
• At least 3-5 years (PhD or MSc) of experience in a comparable position and/or work environment is required.
• Interpersonal skills: pro-active, team player, entrepreneurial, can-do mentality, organizational sensitivity, stakeholder management.
• Essential communication skills: fluency in English, oral, writing and presentation
• Specific hands-on experience in one or multiple of the following focus areas is desired: (preferably) formulation development, chemistry and/or analytics.
• Demonstrated competency in writing and reviewing the CMC regulatory submission documentation (IND/IMPD/NDA/BLA) and answering any possible CMC regulatory questions is an advantage.
• Network in (local) biotech industry is a pre.
• Experience in project management and project team
• Experience with CDMO selection and management is desired.

Our offer:

• Be part of a dynamic group of experienced drug development experts
• Enjoy a company culture that prioritizes work/life balance
• Flexible remote working options
• Competitive salary along with a bonus plan
• Excellent secondary benefits, including pension
• Engage in diverse projects and work with a wide range of clients
• Work alongside with a team of friendly and supportive colleagues

Interested?

Contact Us

Please attach your CV and short motivation letter to our contact form! For more information, you can also contact us at +31 (0)135348272.