Career

For the development of the various projects we run for our clients, we are currently looking for:

Career

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 Regulatory Affairs

Company profile
3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and the Pivot Park in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts aims to cover 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.

Job description
For the development of the various projects we run for our clients, we are looking for a regulatory affairs expert with at least 7 years experience in global regulatory affairs, who is able to look beyond his or her borders and has an ambition to grow in a young and growing organization.

Requirements & roles
• Knowledge of and experience in global regulatory requirements (including CMC) for the development and registration of new medicinal products (chemical entities and biologicals)
• Knowledge and experience in CMC regulatory affairs is a pre
• Experience in preparation and submission of clinical trial applications
• Experience in preparing regulatory strategies for all stages of drug development
• Experience in writing and reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, CMC, nonclinical and clinical dossier (eCTD) overviews/summaries, DSURs/PSURs, pre-IND/End-of-Phase 2/scientific advice briefing/background packages, target product profiles, product information/labeling documents, risk management plans (RMPs), agency response documents, etc.
• Experience in preparation and submission of scientific advice and orphan designation applications and peadiatric investigational plans (PIPs)
• Experience in companion diagnostic regulations is a pre
• Experience in contacts and meetings with regulatory agencies
• Project coordination and project team participation
• Demonstrated competency and experience in all stages of drug development within the pharmaceutical industry
• Essential communication skills: good oral, writing and presentation skills
• Essential personality skills: pro-active, team player, entrepreneurial, can work under time pressure, can-do mentality and ability to put yourself in the position of our clients.

Interested? Send your CV and short motivation letter to 3D-PharmXchange at info@3d-pxc.com.

For more information you can contact Ronald van der Geest on +31 (0)13 5348272.

Acquisition is not appreciated!

Business Development Manager

JOB DESCRIPTION
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 clients are leading pharma companies as well as innovative biotech start-ups.

We are looking for a Business Development Manager for The Netherlands & Western Europe who is able to drive the business forward to achieve our ambitious goals. The ideal candidate is energetic, team player and a self-starter. You will be a first contact person for our (new) clients and will coordinate and interact with various team members. The position will require significant field activity. Within this position you report directly to the management team.

TASKS
- Lead the business development activities within 3D-PharmXchange
- Follow-up of existing leads as well as creating new leads with all kinds of clients, ranging from SMEs to worldwide multinationals.
- Develop and implement strategic and operational plans to achieve revenue objectives
- Take initiative to enhance 3D-PharmXchange’s proposition and development of new concepts
- Responsible for go to market strategy and execution for expansion within Europe
- Contribute to appropriate processes to provide timely and accurate management information related to forecasts, market intelligence and industry trends
- Build and maintain a strong network within the pharmaceutical and biotech companies
- Identification of and attendance at relevant conferences within Europe

REQUIREMENTS & QUALIFICATIONS
- 3 – 8 years commercial work experience in pharmaceutical and/or life science industry
- Excellent communication, relationships management and sales skills
- Advanced knowledge on the way integrated drug development programs are designed and executed
- Experience with Salesforce is preferred
- Fluent in Dutch and English, German is a plus
- Driving license
- Brings a significant network in the innovative life sciences sector

ESSENTIAL PERSONAL SKILLS
- Enthusiastic and easy connector with excellent negotiation skills
- Excellent communication and presentation skills
- Result-driven and customer focus
- Team player
- Multi-tasking and prioritization capability

Interested? Send your CV and short motivation letter to 3D-PharmXchange at info@3d-pxc.com.
For more information you can reach us on +31 (0)13 5348272.

Acquisition is not appreciated

Consultant CMC Development Small Molecules

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

JOB DESCRIPTION
For the various projects that we are running for our clients, we are looking for a consultant Chemistry Manufacturing and Control (CMC) development Small Molecules. As a consultant, you will work on the development of pharmaceutical compounds, are able to look beyond borders and have an ambition to grow in a young, expanding and dynamic organization. The development, manufacturing, and analytics of drug substances and drug product will generally be performed by external parties. Therefore, selection and control of CMOs will be an important part of your task. In addition, you are responsible for the entire CMC development and for writing development reports, protocols, and documents for regulatory purposes.

REQUIREMENTS
• MSc or PhD in the area of (Analytical) Chemistry, Pharmaceutical Sciences, or Process T0echnology
• At least 5 years of experience in a comparable position and/or work environment is preferred
• Essential communication skills: fluency in English, oral, written and presentation skills
• Extensive experience in writing development reports, protocols, and documents for regulatory purposes
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality and ability to put yourself in the position of our clients

In addition, we expect a Consultant CMC small molecules to meet at least some of the following requirements;
• Demonstrated competency, experience, and knowledge on CMC development and manufacturing requirements from early to late phase within the pharmaceutical industry
• Experience in project coordination and project team participation

Interested? Send your CV and short motivation letter to 3D-PharmXchange at info@3d-pxc.com. For more information, you can contact Nina van Erp on +31 (0)13 5348272.
Acquisition is not appreciated

Consultant CMC Biologicals

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

JOB DESCRIPTION
For the various projects that we are running for our clients, we are looking for a consultant Chemistry, Manufacturing and Control (CMC) Biologicals. Depending on the assignment you may be working on any aspect of CMC development for new Biologicals; both in a managing role, or as a Subject Matter expert. Thus, your experiences in early and late stage process development, analytical assay development, CMC regulatory elements, manufacturing of biologicals, 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, are critical elements of the role.

REQUIREMENTS
• PhD (preferred) or MSc in the area of Bio(process)technology, (Analytical) Chemistry, Pharmaceutical Sciences.
• At least 5 years of experience in a comparable position and/or work environment is preferred
• Essential communication skills: fluency in English, oral, written and presentation skills
• Extensive experience in writing development reports, protocols, and documents for regulatory purposes
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality and ability to put yourself in the position of our clients

We expect a Consultant CMC Biologicals to meet the following requirements;
• Demonstrated competency, experience, and knowledge on CMC Biologicals development and manufacturing requirements from early to late phase within the pharmaceutical industry
• Network in (local) biotech industry
• Specific experience in analytical development as well as regulatory experience is desired
• Experience in project management and project team participation

Interested? Send your CV and short motivation letter to 3D-PharmXchange at info@3d-pxc.com. For more information, you can contact Nina van Erp on +31 (0)13 5348272.
Acquisition is not appreciated

Consultant Regulatory CMC

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

JOB DESCRIPTION
For the various projects that we are running for our clients, we are looking for a consultant Regulatory Chemistry Manufacturing and Control (CMC). As a CMC Regulatory consultant you will be working in a multi-disciplinary team and will be responsible for giving the team (incl. e.g. the CMC lead; process development rep, analytical rep) regulatory guidance and direction in order to finally arrive at a dossier that will meet regulatory expectations. The CMC Reg consultant must be able to both help develop CMC regulatory strategies as well as be hands on and deliver regulatory documentation related to CMC, including e.g. comparability protocols, submission documents such as IND, IMPD, etcetera.

REQUIREMENTS
• MSc or PhD in the area of (Analytical) Chemistry, Pharmaceutical Sciences, or Bio(process)technology
• At least 5 years of experience in a comparable position and/or work environment is preferred
• Essential communication skills: fluency in English, oral, written and presentation skills
• Extensive experience in writing documents for regulatory purposes
• Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality and ability to put yourself in the position of our clients

In addition, we expect a Consultant Regulatory CMC to meet at least some of the following requirements;
• Demonstrated competency, experience, and knowledge on CMC development and manufacturing requirements from early to late phase within the pharmaceutical industry
• Preferred experience with both small molecules and biologicals
• Experience with agency interactions
• Experience in project coordination and project team participation

Interested? Send your CV and short motivation letter to 3D-PharmXchange at info@3d-pxc.com. For more information, you can contact Nina van Erp on +31 (0)13 5348272.
Acquisition is not appreciated