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Galenic R&D Specialist
hace 3 meses
¿Dónde vas a trabajar?
In the purpose of international expansion, a consolidated and well-established pharmaceutical company decided to open a new manufacturing facility and R&D premises in the area of Barcelona. We are looking for a Galenic R&D Specialist who will drive the product development from concept to final launch.
¿Qué harás en tu nuevo puesto?
You will have the following responsibilities:
Drive product development from concept to final launch: develop a target quality profile of product, design of development and experiments in all stages of R&D.To be involved in evaluation of API's, excipients, and packaging materials for R&D purposes.Conduct re-engineering of reference drugs.Develop the composition of new products.Develop methods of manufacturing of new products (prototype development, scale up and technology transfer).Preparation of protocols and reports for the technological development of new products according to GMP and ICH regulations.Preparation of formulation tests.Design and preparation of pilot batches and transfer of new products to an industrial production plant.Design and preparation of manufacturing guides for new products.Design and preparation of protocols and reports for process validation of new development and transfer products, according to GMP and ICH regulations.Maintenance of properly qualified equipment and facilities and updated SOPs inside technological R&D laboratory. Concerned calibration of instruments and logbook.Perform their duties following the quality criteria set by the Company.Coordinate the execution of the Validation Campaigns.Evaluate the technical documentation of the potential processes to be transferred (Process and analytics).Follow-up the Tech Transfer runs and Scale-Up batches in order to assure the right performance of these batches. Prepare the Tech Transfer report.Preparation of documents for Module 3 Quality. ¿A quién buscamos (H/M/D)?You must meet the following requirements:
Degree in Chemistry Engineering, Pharmacy, Biotechnology, Chemistry or similar.Postgraduate or doctorate training would be an asset.Work experience in biopharmaceutical and/or pharmaceuticals industry from 2-3 year.To be launched at least 1 product is a plus.Experience in development of aseptic products is a plus.Additional education of seminars and trainings on the topics of R&D, QC and QA is a plus.Formation of documents for Module 3 Quality.Meticulous attention to detail and the ability to follow precise procedures.Strong knowledge of current EU-GMP requirements, Ph. Eur, EMA, FDA, ICH guidelines and QbD.Ability to communicate into English and Spanish effectively and clearly, both written and verbal. ¿Cuáles son tus beneficios? Deep experience in the opening of a new manufacturing and R&D facility in Spain.Opportunity to develop the project from the very beginning.Competitive remuneration, according to proven experience.Personal development plan according to the responsibilities and assigned targets.