Careers At 3D

No drug is developed by a single person. We understand that it takes teamwork, perseverance to realize something this big. The 3D team works hard with room to laugh and is looking to expand.

If you are interested in 3D-PharmXchange, we invite you to contact us. You are always welcome to visit one of our offices for a coffee and discussion regarding our opportunities.

A Great Team & Atmosphere

At 3D-PharmXchange, you work with an experienced and dedicated team of professionals. Serious business with an informal way of working and room for a few laughs.

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 have the freedom to shape your work. Although 3D-PharmXchange is well-known as an experienced partner in drug development, this doesn’t mean it is all about business. Our main aim is to centralize and empower our consultants. Not only professionally but also informally.

We Are Currently Looking For

Join our team of Dedicated Drug Development experts today.

3D-PharmXchange is interested in high-level experts in all key drug development disciplines. Our colleagues 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. Next to the open positions, be reminded that we also appreciate open applications and are always eager to discuss future collaboration.

Vacancy : 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 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 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 Nina Lemmers-van Erp at nina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72

Vacancy : Consultant CMC

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 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 biological (including ATMP) or small molecule; both in a managing role, and as a Subject Matter Expert. Thus, your experiences in early and late stage process development, including formulation development, analytical assay or method development, CMC regulatory trajectories, manufacturing of Drug Substance/API or Drug Product, Technology Transfers, and selection and management of CROs and CMOs are all key assets for this role. Reviewing development and validation protocols and reports, and writing documents for regulatory purposes, is part of the role.

Requirements

PhD (preferred) or MSc in the area of Bio (process) technology, Chemistry,
Analytical Chemistry, Pharmaceutical Sciences.
Demonstrated competency, experience, and knowledge in CMC development and
manufacturing requirements from early to late phase within the pharmaceutical industry.
At least 5 years 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 skills.
Specific hands-on experience in one or multiple of the following focus areas is desired:
upstream processing of Biologicals (fermentation; cell culture); process chemistry,
analytical assay or method development.
Demonstrated competency in writing and reviewing the CMC regulatory submission documentation
(IND/IMPD/NDA/BLA) and answering any possible CMC regulatory questions.
Network in (local) biotech industry.
Thorough experience in project management and project team participation.
Experience with CRO and/ or CDMO selection and management is desired.

Interested?

Send your CV and a motivation letter to Nina Lemmers-van Erp at nina@3d-pxc.com. For more information, you can also contact her at +31 (0)13 5348272.

Vacancy : Business Development Manager

Company profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and with a side offices in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our clients are leading pharma companies as well as innovative biotech start-ups.

Job description

We are looking for a Business Development Manager who is able to drive the business forward to achieve our ambitious goals. The ideal candidate is energetic, a team player and a self-starter. You will be the 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
Acquisition of projects in different stages of drug development including following up with leads, coming up with value propositions, writing proposals, negotiation and closing with all kinds of clients, ranging from SME’s to worldwide multinationals
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 in existing markets and support or lead (depending on seniority level) execution of further expansion in 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

Requirements & qualifications

Relevant master degree (life sciences preferred)
A minimum of 5 years commercial work experience in pharmaceutical and/or life science industry
Excellent communication, relationships management and sales skills
Knowledge on the way integrated drug development programs are designed and executed
Fluent in English and Dutch, German is a plus
Brings a significant network in the innovative life sciences sector
Willingness to travel
Knowledge on deployment of social media to support business development and company branding is a big plus

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 Nina Lemmers-van Erp at nina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72

Vacancy : Consultant Regulatory Affairs - CMC

Company profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and a side office in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, chemistry, manufacturing and control (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 Affairs – CMC). As a CMC Regulatory Affairs 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 regulatory consultant must be able to both provide support in developing CMC regulatory strategies as well as be hands on and deliver regulatory documentation related to CMC, including e.g. comparability protocols and CMC sections of regulatory documents such as IMPD and IND.

Tasks

MSc or PhD in the area of (Analytical) Chemistry, Pharmaceutical Sciences, or Bio(process)technology
Knowledge and experience in CMC regulatory affairs
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 Affairs – 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
Preferrably experience with both small molecules and biologicals
Experience with health authority interactions
Experience in project coordination and project team participation

Interested?

Send your CV and short motivation letter to Nina Lemmers-van Erp at nina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72