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!

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 non-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 (bio-)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 non-clinical development to join our team of consultants. The ideal candidate has a background in ADME (preferred) and Toxicology and is able to look beyond his or her borders and has an ambition to grow in a young and growing organization. Training and/or coaching will be provided in specific areas if needed.

Minimal requirements

  • PhD or equivalent, or MSc degree in Life Sciences, with experience in drug development or similar field
  • At least 3 years of experience as an ADME study director, non-clinical project manager or other drug development role
  • Communication skills: good oral, writing and presentation skills
  • Personality skills: pro-active, team player, results-oriented, 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):

  • Experience in conducting or monitoring drug metabolism studies
  • Experience in designing, monitoring or conducting safety (toxicology) studies at CRO’s and analyzing/presenting data
  • Knowledge of and experience in global regulatory requirements for the development and registration of new medicinal products (chemical entities and/or biologicals)
  • Experience in drafting and reviewing biocompatibility and/or safety assessments, researching literature and toxicology database resources, and summarizing information
  • Experience in writing and/or reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, IMPD, (non-)clinical dossier (eCTD), etc.
  • Understanding of Good Laboratory Practice (GLP) regulations
  • 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 Lemmers-van Erp at +31 (0)13 53 482 72

 

Aquisiton is not appreciated!

Consultant CMC Biologics

Company Profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm with offices in Tilburg and Oss. We are a dedicated team of Drug Development experts covering 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 mainly early phase biotech, but we also support leading big pharma companies.

Job description

Our CMC Biologicals team, specialized in delivering CMC support to companies developing a Biological Drug, is seeking to expand with an enthusiastic colleague. Depending on the customer project you may be working on any aspect of CMC development for new Biologicals; both in a managing role, and as a Subject Matter expert. Thus, your experiences in early and late stage Biologicals process development, analytical assay development, CMC regulatory trajectories, 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, may be part of the role.

Requirements

  • PhD (preferred) or MSc in the area of Bio (process) technology, (Analytical) Chemistry, Pharmaceutical Sciences.
  • Demonstrated competency, experience, and knowledge in CMC Biologicals development and manufacturing requirements from early to late phase within the pharmaceutical industry
  • At least 5-10 years of experience in a comparable position and/or work environment is required
  • Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality and ability to put yourself in the position of our clients
  • Essential communication skills: fluency in English, oral, writing and presentation skills
  • Specific experience with upstream processing of Biologicals – i.e. fermentations; cell culture is highly desired
  • Specific experience in analytical development as well as regulatory experience is desired
  • Network in (local) biotech industry
  • Thorough 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 at +31 (0)13 5348272.

 

Acquisition is not appreciated

Office Manager

 

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

3D-PharmXchange is looking for an Office Manager to expand our team. We are a growing company within the life sciences with offices are located in Tilburg and Oss, the Office Manager will mainly be working from Tilburg. The ideal candidate is energetic, well-organized and a self-motivator. You will coordinate and interact with various members of the team and are a first contact person for our clients. This role is ideal for a young professional who can work independently and has a service and support minded approach. We offer a diverse, dynamic position in a growing company with possibilities of personal and professional growth.

 The main tasks are as follows:

Office Management:

  • First point of contact for our guests
  • Processing and distribution of incoming (e-)mail and phone calls
  • Arrange business travel and hotel itineraries and coordinate all aspects of global and regional travel requirements
  • Overall support of the Management Team
  • Schedule management; schedule meetings, send meeting invitations, plan and schedule regular staff meetings
  • Purchasing of groceries and general office supplies
  • Organizing events and meetings

 Sales, Marketing and Communication:

  • Support sales processes, confirm meetings, help preparing presentations and follow up materials
  • Help organizing client events, coordinate invitations, arrange venue and register participants
  • Keeping website and Social Media up to date
  • Planning and support for business events
  • Overall support of the BD manager

 Administration:

  • Writing of support letters and CDA’s/Contracts
  • Creating templates and layout documents
  • Processing incoming post/sending letters and packages
  • Taking minutes

 Requirements and qualifications

  • Minimal MBO 4, preferably HBO degree
  • Starter level, no experience necessary
  • Available for a minimum of 3 days a week
  • Proficiency with Microsoft Office programs, including Word, Excel and PowerPoint
  • Fluent in Dutch and English (spoken and written)
  • Pro-active personality, enjoying a dynamic environment with a multitude of tasks
  • Service oriented and commercial mindset
  • Excellent organizational skills and communicational skills

 

Interested? Send your CV and short motivation letter to Nina Lemmers-van Erp, at nina@3d-pxc.com.

 

Acquisition is not appreciated!