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Una empresa en crecimiento en el sector farmacéutico busca un LCM Analytical Development Technician para su equipo en Barcelona. El rol incluye el desarrollo y validación de métodos analíticos, gestión de documentaciones, y análisis de resultados de estabilidad. Requiere experiencia en entornos GLP/GMP y un título en ciencias de la vida. Un ambiente de trabajo colaborativo y enriquecedor te espera para ayudar a proporcionar medicamentos de calidad accesibles en todo el mundo.
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Galenicum
Barcelona, Spain
Other
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Yes
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559771330159417753632460
1
23.07.2025
06.09.2025
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BELIEVE IN LIFE. Join a company that takes you further!
Galenicum is one of the fastest growing companies in the pharmaceutical sector! We are enthusiastic about life, devoting our talent and effort to providing high-quality affordable pharmaceuticals worldwide.
People are the key to our present and future success, so we carefully select candidates that meet the requirements for each position, however most importantly, who also fit with our cultural DNA and values.
Here’s the lowdown on what your role will actually look like (spoiler alert: it’s awesome!)
We are looking for a LCM Analytical Development Technician to join our Laboratory Team.
What you'll be rocking:
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 CROs and CMO’s in reference to the analytical development.
Analysis of results of preliminary stabilities of developing products and stabilities for dossier submission. Interpreting results and evaluating trends.
Management and review of the documentation for the release of API, excipients and finished products required for dossier submission.
Support during transfer, validation, and stability studies.
Assist with method development, transfer, validation, and routine sample analysis to support process development, pilot production, scale-up batches, changes of API suppliers, new packaging or new markets for the registered products.
Design experimental plans based on the defined deliverables, planning the activities to meet the project timelines by working closely with project managers or other departments such as regulatory affairs or quality assurance.
Work with Pharmaceutical Development, Manufacture, Quality Control and other Operations groups to troubleshoot and improve existing analytical methods.
Prepare and/or review technical protocols, reports, and Standard Operating Procedures (specifications and analytical methods) as needed.
Respond to deficiency letters, regulatory agencies, and clients regarding analytical development activities.
Perform impact evaluations and change controls.
Present and discuss data at project and department meetings.
Prepare SOPs for General Laboratory Practice and Laboratory Instruments.
Maintain and ensure a safe laboratory environment and work practices.
What you bring to the table:
- Minimum 2-3 years of experience in analytical development in GLP/GMP environment, with proven experience in development and validation of analytical methods such as HPLC, UPLC, LC-MS, GC, UV, DSC, PSD, potentiometric titration, UV-Vis, IR, AA, KF titrations, and dissolution tests.
- Valuable experience in monitoring stability studies, analytical transfers from CROs to CMO’s, and compiling technical documentation for obtaining MA internationally.
- Knowledge of international guidelines EMEA, FDA, ANVISA, ICH, and ISO is highly valuable.
- Proficiency in MS Office.
Educational qualifications:
- Degree in life sciences, preferably in Chemistry.
- Master’s degree in Analytical Chemistry and/or Pharmaceutical Industry.
- Excellent command of English and Spanish, spoken and written.
Your key superpowers:
- Project management and leadership skills. Influencing, persuasive, and encouraging.
- 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.
- Ability to work under pressure and meet deadlines.
- Prioritization skills for multiple tasks.
- Collaborative working style and team spirit.
- Attention to detail and good communication skills.
- Ability to absorb, digest, and relate detailed scientific, quality, and regulatory information.
- Supportive nature and ability to build effective relationships.
- Excellent written and oral communication skills.
- Willingness to learn and apply new skills.
We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you?
Come aboard. Believe in life