Galenic R&D Specialist

• Pharmaceutical company with new manufacturing facility in Barcelona|Career opportunities and development.

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.

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.

• 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 the proven experience.


• Personal development plan according to the responsibilities and assigned targets.


• Flexible work schedule.

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.