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.
Requisitos:
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.
* Willingness and availability to work the afternoon shift (2:00 PM – 10:00 PM).
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