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 Clinical Development

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 Clinical Development.
As a consultant, you will be responsible for the development of clinical strategy and clinical operations of (bio)pharmaceutical compounds. You will be involved in drafting clinical development plans of clinical trials and documentation for regulatory submission.
You are
• Responsible for the clinical development strategy of an investigational compound, including the definition of milestones and Go/NoGo criteria
• Being able to translate biomarker data to decisive proof-of-concept studies
• Responsible for the design, execution and reporting of clinical trials according to timelines and within budget
• Responsible for the writing of essential documents e.g. Clinical Trial Protocol, IB etc.
• A clinical representative in Scientific Advice meetings at regulatory authorities (EMA, FDA)
• A clinical representative in a cross functional collaborative environment.
• An equal and expert discussion partner in the communication with KOL’s
• Managing external partners/service providers
• Guiding operational clinical activities
• Coordinating of project management activities to ensure timely, uniform and quality delivery of the services provided to our clients

REQUIREMENTS
• Relevant academic background in biomedical field, preferably PhD
• Experience with (early) clinical drug development
• Experience in the area of pharmacokinetics is a pre
• 4 - 5 years’ experience in the biotech or pharmaceutical industry;
• Evidence of good scientific and clinical judgment, flexibility, and resilience
• Up-to-date knowledge of legislation and regulations and ICH-GCP guidelines;
• Experience with Scientific Advice meetings at EMA or FDA is a pre.
• Well-developed organizational talent
• Strong sense of meeting milestones, timelines & budgets
• Excellent communication and presentation skills
• Excellent writing skills (English), particularly with respect to clinical protocol and reports
• Ability to work independently and in a team environment
• Capable of effectively managing multiple deadlines and projects
• Ability to adapt to rapidly evolving situations and needs
• Strong commitment to delivering high-quality work
• Strong interpersonal and communication skills to drive results in a cross functional collaborative environment.

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

(Senior) 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, medical devices 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. 3D-PharmXchange employees are able to look beyond borders and have an ambition to grow in a young, expanding and dynamic organization. To strengthen our team, we are looking for an experienced (Senior) Consultant CMC – Biologicals.

JOB DESCRIPTION
We are looking for a (senior) consultant Chemistry Manufacturing and Control (CMC) - Biologicals. As a (senior) consultant, you will work on customer projects related to development of biopharmaceutical compounds. Our clients usually request a strategic person with hands-on experience. Depending on the project, you will be responsible for managing the entire CMC development, where your experience in process development, manufacturing, and analytics help you lead teams and challenge other team members. Project Management is one of your core competences. You have a solid scientific background and will be involved in writing development protocols, reports, and documents for regulatory purposes.
Our customers will generally outsource elements of development, manufacturing, and analytics of drug substance and drug product to external parties. Therefore, selection of CMOs and CROs, tech transfer and management of CMOs/CROs will be part of your responsibilities.

REQUIREMENTS
• MSc (or, preferably, PhD) in the area of (Analytical) Chemistry, Pharmaceutical Sciences, or Bio(process)technology
• 10+ years of experience in early to late stage Biologics development
• Experience in managing outsourced activities
• Experience in (regulatory) requirements related to different phases of product development
• Experience in the service industry is preferred
• Experience in Drug Product formulation 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.
• Strong project management skills
• Essential personality skills: pro-active, team player, entrepreneurial, 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 Nina van Erp 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. 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 (Senior) Consultant Chemistry Manufacturing and Control (CMC) Development Small Molecules. To strengthen our group of Consultants CMC Development Small Molecules, we are looking for a candidate with strong knowledge of and experience with CMC development during the entire development trajectory.
As a CMC Consultant, you will work on the development of pharmaceutical compounds, are able to look beyond borders, have a problem-solving attitude, and have an ambition to grow in a young, expanding and dynamic organization. The development, manufacturing, and analytical control of drug substance and drug product will generally be performed by external parties. Therefore, collaboration with Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) and supervision of all outsourced activities will be an important part of your tasks. In addition, you are responsible for (part of) the CMC development strategy of clients’ projects and for writing and/or development reports, protocols, and documents for regulatory purposes.

REQUIREMENTS
• MSc or PhD in the area of Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or Process Technology
• At least 5 years of experience in a comparable position and/or work environment is preferred
• Knowledge about CMC development requirements in all stages of development
• Ability to define phase-appropriate CMC strategies for our clients’ projects, extensive experience in writing and reviewing development and manufacturing protocols and reports, knowledge of relevant ICH guidelines, and writing documents for regulatory purposes
• Experience in project coordination and project team participation
• Experience with CRO and/or CDMO management is preferred
• Essential communication skills: fluency in English, orally and in writing, and presentation skills

Interested? Send your CV and short motivation letter to 3D-PharmXchange at info@3d-pxc.com. For more information, you can contact Nina Lemmers - van Erp on +31 (0)13 5348272.
Acquisition is 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 DESCRIPTON
For the development of the various projects we run for our clients, we are looking for a (junior) regulatory affairs expert to join our team of regulatory affairs consultants. The ideal candidate is able to look beyond his or her borders and has an ambition to grow in a young and growing organization. Coaching will be provided in specific areas if needed.

Minimal requirements
• Master’s degree in Life Sciences, e.g. Biomedical Sciences, Medical Biology, Pharmacy, Chemistry
• At least 3 years of experience in a regulatory affairs role
• Communication skills: good oral, writing and presentation skills
• 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

Experience in a number of the following areas and roles (not all required):
• Knowledge of and experience in global regulatory requirements for the development and registration of new medicinal products (chemical entities and biologicals)
• Knowledge and experience in CMC regulatory affairs
• Experience in preparation and submission of clinical trial applications
• Experience in preparing regulatory strategies for all stages of drug development
• Experience in writing and/or reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, 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 pediatric investigational plans (PIPs)
• Experience in companion diagnostic regulations
• Experience with additional Risk Minimization Measures
• Experience in interactions 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

Interested? Send your CV and short motivation letter to 3D-PharmXchange at info@3d-pxc.com.
For more information you can contact Nina Lemmers at +31 (0)13 53 482 72

Acquisition is not appreciated!