Stability Technician

Galenicum; Esplugues de Llobregat; Presencial; EUR 28.000 - 38.000; Jornada completa

Descripción de la vacante

Galenicum is seeking a Stability Technician to join our Laboratory Team in Spain. You will revise stability reports for R&D projects, manage stability studies with CMOs, and ensure timely analysis and documentation.

The role requires GLP/GMP analytical development experience and coordination across departments. Educational background in life sciences (Pharmacy preferred) and fluent English and Spanish are required.

Formación

• Minimum 1–2 years in analytical development in GLP/GMP environments.
• Experience in validating and developing methods (HPLC/UPLC/LC-MS).
• Knowledge of regulatory guidelines (EMEA/FDA/ICH/ISO) is valuable.
• Experience organizing and revising stability reports and protocols.

Responsabilidades

• Revise stability reports from R&D and external labs/CMOs.
• Organize and revise stability results across studies and transfers.
• Monitor ongoing stability studies and review trends and deviations.
• Approve stability protocols and ensure timely follow-up actions.
• Maintain up-to-date results on shared platforms for departments.
• Create and maintain SOPs; train staff accordingly.

Conocimientos

Analytical development

HPLC

UPLC

LC-MS

GMP/GLP

Dissolution testing

Data analysis

MS Office

Educación

Life sciences degree (Pharmacy preferred)

Herramientas

MS Office

Descripción del empleo

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 Stability Technician to join our Laboratory Team.

What you'll be rocking:

• Revision of stability reports issued R&D projects done by R&D (lab) and/or performed by externalised companies.
• Organize, manage and revise stability reports and results as part of Technical Transfers generated at 2n CMOs, including follow-up for Galenicum’s factory (SAG Manufacturer).
• Management and revision of on-going stability studies (products controlled or/and released by the lab, products manufactured in third CMOs or products where Galenicum is involved only as a broker).
• Evaluation of trends and pourabilities on a regular basis in order to detect tendency and take preventive actions with CMOs.
• Revision and approval of stability protocols, approval of stability protocols & reports, follow-up of stability results at each time point, review of results and trends.
• Up-to-date results in a common platform that can be consulted by each department.
• Inform to inform all related departments of any expected deviation and coordinate new analysis if necessary.
• Create and maintain SOP related with these activities and train accordingly the staff.

What you bring to the table:

• Minimum 1-2 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, ICH and ISO.
• Experience in MS Office.

Educational milestone:

• Degree in life sciences, preferably in Pharmacy.
• Advanced level of English and Spanish, spoken and written.

Your key superpowers:

• Motivated, proactive, dynamic, methodical, organized and decisive.
• Self-sufficient, influencing and leadership skills.
• Strong analytical skills and problem solving.
• Highly responsible and capable of working under pressure to meet deadlines.
• Ability to prioritize multiple tasks
• Good team player.
• Strong organizational, planning and time management skills, to achieve project timelines.
• Detail oriented and good communication and research skills.

We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you?