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 an Analytical Validation & Transfer Specialist to join our R&D; Operational Team. In this role, you will take autonomous ownership of technical documentation, method transfers, and cross-functional coordination with our external partners (CROs/CMOs) and internal business units.

What you'll be rocking:

- Writing and reviewing Protocols & Reports of analytical validation of new analytical methods for active pharmaceutical ingredients (APIs) and finished dosage forms.
- Writing and reviewing Protocols & Reports for analytical method transfers between different Sites, CROs, and CMOs for active pharmaceutical ingredients and finished dosage forms.
- Cross-functional planning and alignment with QA, RA, and Business Development (BD) to establish and execute priorities for products to be transferred.
- Providing direct technical support to our CROs network (currently 4 CROs) and acting as the main interlocutor between transferring and receiving laboratories.
- Planning and follow-up of microbiological method verifications at CROs, liaising with Madrid support staff.
- Management, detailed review, and critical follow-up of technical documentation and raw data provided by CROs and CMOs regarding analytical validations and transfers.




- Technical follow-up and documentation support for import licenses and customs clearance of analytical materials and products.
- Management and logistics of reference standards, working standards, finished product samples, HPLC columns, and materials needed for external testing.
- Tracking of departmental project expenses (quotes and invoices) for materials and transfer costs in close collaboration with Finance.
- Preparation of annual Budgets and Best Estimates (BE) for analytical method transfer activities.
- Drafting technical answers to deficiency letters and agency/client requests regarding AVT activities.
- Drafting technical reports, SOPs, and proposing continuous workflow improvements within R&D; Operational.
- Collaborating in the preparation and review of analytical dossiers (Module 3 / CTD) for product registration.

What you bring to the table:

- Minimum 1–2 years of experience in Analytical Validation & Transfer activities within a GLP/GMP environment, preferably in the Pharmaceutical Industry.
- Solid technical understanding of key analytical methods (HPLC, UPLC, LC-MS, GC, UV-Vis, KF titration, Dissolution tests) to review protocols, data, and analytical reports.
- Demonstrated ability to coordinate external partners (CROs/CMOs), handle documentation workflows, and work autonomously.
- Very valuable to have knowledge of international guidelines: ICH (ICH Q2), EMEA, FDA, as well as emerging/regional regulatory frameworks (SFDA, ANVISA/COFEPRIS).




- Familiarity with budget follow-up, cost tracking, or technical customs/import requirements is a strong asset.
- Proficiency in MS Office and standard documentation tools.

Educational milestone:

- Degree in Life Sciences or Health Sciences, preferably in Pharmacy or Chemistry.
- Master's degree in Analytical Chemistry, Pharmaceutical Industry, or Regulatory Affairs is an asset.
- Excellent level of English and Spanish, both spoken and written (scientific and business).

Your key superpowers:

- High autonomy, self-sufficiency, and strong project ownership to drive transfers independently.
- Strong organizational, planning, and time-management skills to align cross-functional teams (QA, RA, BD, Finance) and meet critical timelines.
- Detail-oriented mindset with sharp analytical and problem-solving skills when reviewing third-party raw data.
- Clear communication and interpersonal skills to build effective working relationships with internal teams and international external partners.

What makes Galenicum a top-tier workplace?

- A challenging company, and a dynamic team to work with.
- A Workspace to enjoy: pleasant, sustainable, and architecture-awarded office.
- A adaptable schedule to match your preferences and workload.
- A training offer to learn beyond your job with a broad set of topics: Galenicum Laude.
- Health insurance coverage to feel cared.
- Food to keep your energy up: subsidized meals in our office restaurant Popina.
- Gym to help you maintain a healthy lifestyle.
- Flexible remuneration.
- And, very important! A Buddy to help you land smoothly in our company since day 1.

We’re looking for someone who works hard, plays hard, and laughs harder. Sound like you? Come aboard. Believe in life.

📌 Analytical Validation & Transfer Specialist (Esplugas de Llobregat)
🏢 GalenicumVitae
📍 Esplugas de Llobregat