The project: The project is the development of an ocular drug delivery device that is to be subjected to a human comfort trial and preclinical animal efficacy trial. The position: Your main focus is to further develop a proprietary technology to fabricate a drug eluting device that is loaded with drug loaded microspheres. This will involve out sourcing certain aspects of the device as well as internal developments where you will be required to develop a method with which to fill the device with microspheres.
The mechanism of filling has to be reproducible and be performed in accordance with various quality and regulatory requirements. Once the filling method has been developed appropriate testing upon sterilisation and packaging will involve drug elution studies.
The position is an opportunity to contribute to drug delivery system as we move from R&D through clinical studies, global submission, and manufacturing to commercialisation. The delivery systems and primary packaging solutions can either be developed from scratch or by sourcing of existing technology but often with the use of external partners.
Your main responsibilities will be:
- Delivering drug delivery device and primary packaging defined deliverables to the clinical development projects. These are to provide sterile and safe drug delivery devices for the human comfort trial and drug deliver y device for animal efficacy experiments.
- To be able to work in cross functional project teams which include development, clinical, manufacturing, regulatory and quality.
- Be able to operate in a Design Control Process for combination products and driving the generation of documentation for submission to appropriate regulatory bodies.
- Together with the team you will be responsible of a human comfort trial and an animal efficacy trial.
- Building up and continuously updating the scientific knowledge on primary packaging and drug delivery devices and combination products.
Representing the project consortium in relation to external suppliers and development partners.
Job requirements
Profile: The ideal candidate:
- Holds a Ph.D. in mechanical, chemical or biomedical engineering, pharmacy or equivalent
- Proven project coordination/management skills with both internal and external stakeholders
- Knowledge of CMC ( clinical manufacturing and control) drug development and experience of regulated work within the pharmaceutical / medical industry
- Has experience with the development of combination products ( drug eluting devices)
- Has experience in ophthalmology, medical devices and or drug delivery
- Has worked in a regulated environment
- Exhibits platform thinking and modular development
- Experience with in-vitro drug elution studies and associated method developments
- You have an interest in drug delivery devices and pharmaceutical packaging solutions.
- You are motivated by facilitating new ideas and ways to work, by finding the essential elements in an often unpredicted development phase and getting the user- and stakeholder requirements in place at the right quality and time.
- You are a strong communicator of ideas, direction and solutions and are able to navigate in an environment with many stakeholders.
- You are fluent in English – spoken and written.
- Furthermore you should be keen on working in a multicultural and interdisciplinary environment.
Information and application
Information: More information about this vacancy can be obtained with prof. dr. ir. Remco Tuinier (e-mail: r.tuinier@tue.nl or dr. A. Dias (e-mail: aylvin.dias@dsm.com). More information about job conditions and application can be obtained with mrs. Arianne Boekema (email: a.d.boekema@tue.nl).
Application: The application should consist of the following parts:
- a brief letter explaining/motivating your interest in the position;
- a detailed Curriculum Vitae, including a list of publications;
- one-page summary of the PhD thesis;
- contact details of two referees;
- proof of English language skills (if applicable);
- any other relevant information.
Please send us your application before September 1st 2015, by using the ‘apply now’-button on top of this page. Review of applications will start as soon as applications are received and will continue until the position has been filled.