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Finished product manager

Description

Galenics (or galenic pharmacy) is the science by which raw materials (active principles) are converted into a medicinal compound or drug (formulation of the finished product delivered to the end-user), the purpose being to confer an external shape to the active principle which makes it suitable for administration to patients with the best possible ease of use and efficacy . The galenic form is the external appearance given to pharmaceuticals to facilitate their administration and dosage and increase the effectiveness of the medication. The administration method may be oral (drops or syrup), sublingual, intra-venous (injections), rectal (suppositories), topical (lotions), transcutaneous or transdermic and inhaled. The galenic development manager is the research scientist in charge of discovering new product formulations and the galenic development of pharmaceutical products, as well as of the managerial aspect of project and team coordination.

Tasks

  • Develop and optimise galenic formulas and processes according to the characteristics of the raw materials and administration method. Take into account whether the drug is aimed at a special patient group, such as the elderly or children to adapt its formulation and flavour.
  • Prepare preliminary formulations for testing on laboratory animals as required by current legislation.
  • Supervise the reformulation of existing products in order to adapt them to current legislation.
  • Evaluate the results obtained from various galenic tests and draw up new proposals for future trials via Active Pharmeceutical Ingredient (API) evaluation.
  • Research new excipients and combinations.
  • Follow-up on the implementation of production process improvements.
  • Verify that the formulation process is suitable for mass production.
  • Coordinate the interdisciplinary teams under his/her responsibility and the relations between the different departments involved (guarantee and quality control departments, or analytical technicians).
  • Ensure the fulfillment of the calibration and verification plan established by the company.
  • Operate under the GLP regulation (Good Laboratory Practice).
  • Draw up the documentation required for quality audits and clinical trials.
  • Be highly familiar with the Vademecum and ICH (International Conference on Harmonisation) manufacturing and risk analysis regulations.
  • Be up to date with the relevant sector patents and proposes new patents to protect novel product inventions .
  • Attend specific conferences and congresses, and publish scientific articles in specialised publications.

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Centre per al desenvolupament professional Porta22

Barcelona Treball (Porta22)
Llacuna, 156-162, 08018 Barcelona
bcn.cat/treball

900533175
Monday to Friday from 9 to 18 h

Generalitat de Catalunya
Unió Europea FEDER
Unió Europea FSE