lavori da Biotecnologia in località Spagna

KYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany and a Liasson office in South Korea, offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA.

KYMOS GROUP is devoted in providing high quality and added value services to its partners and it is highly oriented to innovation, offering services of research, development and quality control in many different fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies.

KYMOS GROUP has a young and dynamic staff of more than 200 employees, and it is committed in promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.

We are seeking a highly motivated Scientist to join our Biologics and Advanced Therapies Quality Control team. This role, reporting to the Department Manager, focuses on the analysis of biological products in a GMP-regulated environment.

Key responsibilities :

• Design, execution, and oversee of analytical method development and validation studiesfor biologic products, including monoclonal antibodies, recombinant proteins, and advanced therapies.
• Hands-on experience with techniques such as HPLC, capillary electrophoresis, ELISA, protein quantification (e.g., BCA, UV), and other relevant biochemical methods.
• Lead and manage assigned development and validation projects, ensuring timely execution, compliance with regulatory requirements, and effective communication with internal and external stakeholders.
• Draft, review, and manage technical documentation including method validation protocols and reports, SOPs, risk assessments, and technical justifications.
• Collaborate with cross-functional teams including Quality Assurance and Marketing to support method development and validation.
• Supervise and mentor laboratory analysts and technical staff during experimental work, promoting scientific excellence and GMP compliance.

Requirements :

• Bachelor's or higher degree in Biochemistry, Biotechnology, Pharmacy, or a related life science field.
• Solid hands-on experience in analytical method development and validation for biologics, particularly using HPLC, capillary electrophoresis, and immunoassay-based techniques.
• In-depth understanding of GMP requirements and ICH guidelines relevant to analytical method validation.
• Experience with HPLC and Capillary electrophoresis developmentwill be considered a strong asset.
• Excellent organizational and documentation skills, with the ability to manage multiple projects simultaneously.
• English level equivalent to Cambridge First Certificate (B2) or higher.
• Willingness and availability to work the afternoon shift (2 : 00 PM – 10 : 00 PM).

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