(Senior) Consultant CMC

Are you seeking a role that offers substantial responsibility, diverse projects, and a supportive team of colleagues within a leading drug development consultancy firm? If so, we invite you to explore the opportunity to join 3D-PharmXchange.

Company profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm with offices in Tilburg, Amsterdam and Oss. We are a Dedicated team of Drug Development experts covering the key areas drug development; pre-clinical, clinical, CMC, regulatory affairs and project leadership. In addition, we provide out-licensing and interim management support. Our many clients are mainly early phase biotech, but we also support leading big pharma companies.

Job description

Our CMC team, specialized in delivering CMC support to pharmaceutical companies and biotech industry, is seeking to expand with a (senior) consultant CMC. 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/or 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 highly valuable. The role involves reviewing development and validation protocols and reports. Additionally, (co-)writing of regulatory documents is a key responsibility.

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 biotech or pharmaceutical industry.
• At least 5 years (PhD) or 10 years (MSc) 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
• 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.
• Network in biotech and/or pharma industry.
• Thorough experience in project management and project team
• Experience with CDMO selection and management is desired.

Our offer:

• Be part of a dynamic group of drug development experts
• Enjoy a company culture that prioritizes work/life balance
• Flexible remote working options
• Competitive salary along with a bonus system
• 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 to our contact form! For more information, you can also contact us at +31 (0)135348272.