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ANALYTICAL DEVELOPMENT SENIOR TECHNICIAN

Descripción de la oferta de empleo

We are looking for a Analytical Development Technician to join our R&D team located in Esplugues de Llobregat. He/she will be in charge of the following responsibilities:Roles and responsibilities: Development and validation of new analytical methods for active pharmaceutical ingredients, excipients, finished dosage forms and cleanings.Management and review of the documentation provided by CRO’s and CMO’s in reference to the analytical development.Analysis of preliminary stabilities of developing products and review of results of stabilities for dossier submission. Interpreting results and evaluating trends.Support during process development and pilot production.Prepare and/or review technical protocols, reports and Standard Operating Procedures (specifications and analytical methods) as needed.Response to deficiency letters, regulatory agencies and clients regarding analytical development activities.Handling and calibration of analytical instruments.Education:Degree in life sciences, preferably in Chemistry.Master’s degree in Analytical Chemistry and/or Pharmaceutical Industry.Excellent level of English and Spanish, spoken and written.Previous experience required:Minimum 5-7 years-experience in analytical development in GLP/GMP environment, showing proven experience in the development and validation of most of the following analytical methods: HPLC, UPLC, LC-MS, GC, UV, DSC,PSD, potentiometric titration, UV-Vis, IR, AA, KF titrations and dissolution tests.Experience in monitoring stability studies, analytical transfers from CRO’s to CMO’s and compiling technical documentation for obtaining MA internationally.Very valuable to have knowledge of international guidelines EMEA, FDA,ANVISA, ICH and ISO.Experience MS Office.Suitable Skills: Self-sufficient, critical, disciplined, confident, hard-working, creative, motivated, proactive, dynamic, methodical, organized and decisive.Strong analytical and problem-solving skills.Excellent organizational, planning and time management skills in order to design, monitor and enforce work plans.Highly responsible and capable to work under pressure to meet deadlines.Ability to prioritize multiple tasks and execute projects on time in a fast-paced environment.Good team player and collaborative working style.Detail oriented professional with good communication skills.Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.Supportive and able to build effective working relationships. throughout the organization.Excellent written and oral communication skills.Ability to increase technical knowledge and apply new skills.
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Detalles de la oferta

Empresa
  • Galenicum
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 27/11/2024
Fecha de expiración
  • 25/02/2025
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