R&D Analytical Develpment Scientist II (España)

R&D Analytical Develpment Scientist II (España)

06 oct
|
PCI Pharma Services
|
España

06 oct

PCI Pharma Services

España

PCI Pharma Services seeks an Analytical Development Scientist II in Leon, Spain to develop, optimize, validate, and transfer analytical methods supporting pharmaceutical product development, registration, and manufacturing. The role involves managing analytical staff, collaborating across departments, and ensuring compliance with regulatory standards.
Responsibilities
- Develop and optimize analytical methods for small molecules and biologics using multiple chromatographic and immunoassay techniques
- Create and execute method transfer and validation protocols with corresponding technical documentation
- Supervise and mentor analytical development staff on experimental execution and technical matters
- Review analyst-generated data, evaluate trends, and assess analytical findings




- Support regulatory submissions, quality events, and internal/external audits by regulatory authorities

Requirements
- University degree in Chemistry, Pharmacy, Biotechnology, or equivalent field
- Advanced knowledge of U/HPLC, ELISA, and CE method development, optimization, validation, and transfer
- Familiarity with GMP regulations
- Prior experience in analytical development within pharmaceutical or regulated industries preferred
- Strong organizational and communication skills with technical rigor and quality focus
- Fluent Spanish and English, both written and spoken

📌 R&D Analytical Develpment Scientist II (España)
🏢 PCI Pharma Services
📍 España

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