LCM Analytical Development Technician

JR Spain; España; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

An innovative pharmaceutical company, JR Spain, seeks an LCM Analytical Development Technician to join their Laboratory Team. In this role, you will develop and validate analytical methods for pharmaceuticals, manage documentation from CROs and CMOs, and support stability studies. Candidates should have a degree in life sciences, ideally with experience in a GLP/GMP environment and knowledge of HPLC, UPLC, and regulatory guidelines. If you're self-motivated, detail-oriented, and thrive under pressure, we want to hear from you!

Formación

• Minimum 2-3 years-experience in analytical development in GLP/GMP environment.
• Knowledge of international guidelines EMEA, FDA, ICH.
• Excellent level of English and Spanish, spoken and written.

Responsabilidades

• Development and validation of new analytical methods.
• Management and review of documentation for analytical development.
• Analysis of results of preliminary stabilities.

Conocimientos

Analytical problem-solving

Project management

Attention to detail

Team collaboration

Communication skills

Educación

Degree in life sciences

Master's degree in Analytical Chemistry

Herramientas

HPLC

UPLC

LC-MS

GC

Descripción del empleo

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Client:

Galenicum

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

587309478486369894432460

Job Views:

1

Posted:

23.07.2025

Expiry Date:

06.09.2025

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Job Description:

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 CRO’s 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 as regulatory affairs or quality assurance.
• Work with Pharmaceutical Development, Manufacture, Quality Control and other Operations groups to trouble-shoot and improve existing analytical methods.
• 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.
• Perform impact evaluations and change controls.
• Present and discuss data at project and department meetings.
• Preparation of SOP's for General Laboratory Practice and Laboratory Instruments.
• Maintains and ensures safe laboratory environment and work practices.

What you bring to the table:

• Minimum 2-3 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.
• Valuable 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.

Educational milestone:

• 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.

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 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.

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