Analytical Development Scientist – Biological Methods
Por favor, lea detenidamente la siguiente descripción del puesto para asegurarse de que encaja con el perfil antes de enviar su solicitud.
Applications to be sent to:
Integral Responsibility
Responsible for the execution, documentation, and technical integrity of analytical activities related to the development of bioanalytical methods within the organization.
This includes ensuring that all analytical work—method development, validation, transfer, and routine support—is performed in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), data integrity standards (ALCOA+), and internal Quality Management Systems (QMS).
Specific Responsibilities
-
- Review the documentation associated as well as documentation of reports, in accordance with GMP standards. Approve the analytical documentation
- Preparation of presentations and reports results and communicating with the relevant people involved
- Analyze samples of finished product and raw intermediate materials if necessary
- Produce documentation required by the Quality System
- Review the work performed by the analysts and correct deviations from the established methodology.
- Write protocols to describe how to perform the activities required
- Write a transfer and verification protocols and reports and coordinate the analysis
- Organize and might perform Training of new analysts.
- Manage priorities of analytical projects assigned.
- Write procedures and analytical methods for its use in the Biological Laboratory
- Contribute and design practices for the good functioning of the laboratory
- Write technical SOPs when required and participate in their continuous review.
Experience and Personal Skills
-
- Education: A bachelor´s degree in sciences. A PhD would be a plus.
- Languages: Fluent English and Fluent Spanish.
- Experience: 3-5 years (Senior Scientist) of experience as an analytical scientist in R&D;, pharma industry. Expert