Schweiz, Basel-Stadt, Basel
Scientist Ocular Drug Delivery
Europe Biologics Technical Development (PTDE) supports biologics and small molecules parenteral from Phase I into the Market. Our activities encompass process development for Drug Substance (DS) and Drug Product (DP), market formulation design and process development, device development, clinical manufacturing of DS and parenteral DPs, analytical method development, validation and release of clinical supply, development documentation submissions and transfer of development projects to commercial manufacturing.
As a Scientist in Ocular Drug Delivery, you are part of the Department “Pharmaceutical Development and Supplies” within PTDE in Basel, Switzerland.
Pharmaceutical Development & Supplies is responsible for the development of parenteral DP from GLP Tox. up to Launch. Activities encompass formulation and manufacturing process development for all clinical stages and the market, the transfer of product and process to commercial manufacturing sites, commercial product support, line extension development and DP supplies for preclinical and clinical studies (Phases 1-3). The department develops innovative Drug Delivery Systems and is actively innovating the way Roche is performing all unit operations relevant for aseptic DP manufacturing.
Within the department, Drug Delivery is primarily responsible for the evaluation and development of advanced formulations and innovative (sterile) DP, for biologics and small molecules (e.g. traditional small molecules, peptides, oligonucleotides), in defined key strategic areas like long-acting delivery, localized/targeted delivery, high dose formulations etc.
Your major responsibilities in this position are the following:
- Lead the early evaluation of drug delivery systems in the above mentioned key strategic areas, in partnership or internally, focusing on prototyping formulations that integrate advanced formulation features to enable CMC proof of concept and, if successful, animal testing.
- Support the technical development of innovative drug delivery DP in the pipeline (e.g. ocular long acting, subcutaneous high dose etc.), through pre-clinical, clinical phases and market
- Contribute to maintain excellent partnership with a wide range of internal and external stakeholders (in particular Roche Pharma Research and Early Development pRED and Genentech drug delivery)
- Knowledge management of complex multi-disciplinary technical development information, advise on product and development strategies when it comes to implementation of drug delivery approaches in the pipeline
- Authoring and/or supervising publications and patents, and giving presentations, lectures at conferences, and supervision (internships, PhD, Postdocs) of new research activities in drug delivery and DP differentiation
As the successful candidate you hold a Ph.D. in pharmaceutical sciences, chemistry, biochemistry, biotechnology, or related fields, and bring a minimum of 2-5 years of professional experience in industry and/or academia in drug delivery/formulation of biologics, peptides or other new chemical entities, and you have a sound understanding of protein analytics and/or process development of parenteral dosage forms.
- Experience in relevant technologies and processes (e.g. sustained release, targeted delivery, ophthalmology, biopolymers, hydrogels, spray-drying, micro/nano-encapsulation, hot-melt extrusion, injection molding, 3D printing, electrospinning, lyophilisation, biochemical and biophysical analytical techniques)
- Excellent team and collaboration skills combined with efficient communication
- Proven organizational and planning abilities as well as excellent stakeholder management skills
- Strong End to End mindset along all relevant steps of the value chain
- Excellent command of English
- Excellent IT knowledge. Ability to use data analysis and visualization software systems such as Modde, JMP, Matlab, LabView. Experience in automation software and/or database systems would be a plus.
- Strong foundation in a digital mindset and experience in the application of Computational Methods (CFD / in silico prediction) are of advantage
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