- Design and optimization of galenic formulations and manufacturing procedures from preformulating to industrial scale manufacturing.
- Plan, participate and/or supervise the preparation of the formulations within the established deadlines.
- Prepare the medication and the documentation needed for clinical trials.
- Draft and review technical documentation to support launch and regulatory approval of projects.
- Assist in developing and communicating timelines and costs for formulation development projects.
- Draft and review development protocols and design experiments to identify critical quality attributes, critical material attributes, and critical process parameters.
- Carry out the technology transfer to the Production department for the manufacture of industrial batches.
- At least 5 years of experience as a Galenical Scientist
- Proven experience in pharmaceutical formulation development, manufacturing process development
- Experience in pharmaceutical product development for various dosage forms, especially solid dosage forms.
- Experience working in diverse and cross-functional teams;
- GMP, Scientific guidelines (ICH, EMA, FDA, ASEAN...)
- Quality by design / Experimental design, Statistical knowledge
- MS Office (Outlook, Word, Excel, Access,...), Smartsheet
- Experience in Risk assessment
- Degree in pharmacy/engineering, science or an equivalent education.
- English & Spanish ( medium/high level)
- German language is a plus
- Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
- Economic conditions will be according to the experience and skills provided.
- A motivated and committed environment based on a diverse and inclusive culture.
- A specialized team focused on our core activity: Improving our patients' lives.
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Senior Formulation Development Scientist - Sant Joan Despí, España - Neuraxpharm
Descripción
Neuraxpharm is the leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.
Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs, and is expanding its portfolio through its pipeline, partnerships, and acquisitions.
The company has more than 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, and globally via partners in more than 60 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.
Neuraxpharm is searching for a vacancy based in Sant Joan Despi, Barcelona:
Senior R&D Scientist
Design, plan, and supervise the execution of the tasks needed for the galenic development of a pharmaceutical drug product, using the necessary resources, internal or external to the department, to obtain, according to the established quality guidelines (GxP, ICH, ...), all the necessary information for the registration and marketing of new pharmaceutical drug products.
BEING HIS/HER MAJOR ACCOUNTABILITIES:
WE REQUIRE:
WE OFFER:
