Scientist for Biologics and Advanced Therapies Analysis

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 studies for 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 development will 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.

Kymos considers diversity and inclusion as key development priorities, with one of our main goals being to promote a culture that embraces differences and celebrates unique talents. For this reason, we are committed to equal opportunities for all people, regardless of gender, nationality, sexual orientation, gender identity, age, religion or any other personal characteristic.