Formulation Scientist R&d Inhalers
hace 1 mes
Overview:
Supervise, organize, review and evaluate the development and optimization of formulations and galenic processes according to internal SOPs, GMP and GLP regulations, ICH, EMEA and FDA guidelines, avoiding to infringe patents, and reporting the progress to the R&D Team leader.
Ensure the maintenance of necessary stock, prepare documentation (manufacturing batch records, protocols, informative letters, proforma invoice, etc.) and develop/manufacture test products for bioequivalence or registration.
Ensure that the products and processes developed are suitable for a succesful scale-up to commercial manufacturing. Interact with external suppliers and raw material vendors to select the suitable quality of materials to be used for development and manufacturing.
**Responsibilities**:
- Develop and test standard operating procedures (especially the operation of equipment), protocols, specifications, guidelines and documentation for the GMP release necessary to perform the tests scheduled in the department and clinical trials.
- Carry out formulation development experiments.
- Organize and monitor the work of the operators to carry out the schedule set.
- Characterize the reference product, perform literature searches, extract relevant information from patents and scientific publications to develop products.
- Conduct requisitions and stock control maintenance according to forecasts to perform various tests.
- Receive operator’s results of the various galenic tests to archive, analyze, produce reports, dossiers and propose the supervisor tests to improve results, optimize processes and formulations and facilitate decision-making.
- Train new galenic operators in handling machines, meet the area doubts regarding daily operations and monitor proper operation during commissioning of new equipment and compliance with the existing Calibrations Plan for ensuring compliance with procedures and GMP regulations.
Qualifications:
- **Education**: Degree in Pharmacy.
- ** Languages**: Fluent Spanish and English, knowledge of other languages will be an asset.
- ** Experience (years/area)**: 1-2 years of experience in the Pharma industry
- ** Specific Knowledge**:Experience in GMP environment, knowledge in FDA is a plus.
- ** Travels**: As required for specific projects.
- ** Personal skills**:Good analytical skills, accuracy and reliability.
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