ABOUT US:
We are dedicated to the research, design, validation, manufacture, and distribution of anti-allergic vaccines (immunotherapy sector).
We have a Technical, R&D and Clinical Trials headquarter in Zamudio, our only production center for the moment. In this sense, we have a strong growth forecast.
Our value proposition for employees is as follows:
- PEOPLE-CENTRIC: We focus on people.
- SELF-DEMANDING PEOPLE: We promote individual self-demand in pursuit of common achievement.
- CURIOUS PEOPLE: We learn by innovating, valuing the experience that each person can bring to the organisation.
ABOUT THE JOB:
We are looking for a Senior R&D Technician to join our team. He or she will report to the Head of R&D and will provide support to the team within the department.
Mission:
The successful candidate will be responsible for the development, optimization, and validation of analytical methods, as well as the design and execution of experimental protocols focused on the development of biotechnology products, including the production of monoclonal antibodies. In addition, the candidate will actively participate in the planning, monitoring, and execution of stability studies in accordance with applicable regulations. The position requires a highly technical profile, with the ability to work independently, critical thinking skills, and demonstrable experience in a regulated environment.
Main tasks and responsibilities:
- Development, optimization, and validation of analytical methods.
- Independent design and implementation of experimental protocols.
- Development and maintenance of cell cultures for the production of monoclonal antibodies.
- Planning, monitoring, and control of stability studies (ICH).
- Conducting analyses at various time points during stability studies.
- Management and review of results, ensuring compliance with specifications.
- Implementation and execution of laboratory techniques, including:
- ELISA
- SDS-PAGE
- Western blot
- Protein quantification
- Determination of total nitrogen in samples
- Analysis, interpretation, and documentation of experimental results.
- Preparation of technical reports and documentation in accordance with GMP/GLP regulations.
- Collaboration with multidisciplinary teams (Production, Quality, Regulatory Affairs).
- Participation in technology transfer and scale-up processes.
Requirements:
- Education: PhD in Health Sciences (Biology, Biochemistry, Pharmacy, or related fields), or a bachelor’s degree in Health Sciences with a specialized master’s degree and relevant experience in the pharmaceutical industry.
- Experience: At least 4 years of experience in R&D and 2 years in the pharmaceutical or biotechnology industry; demonstrable experience in the development and validation of analytical methods; experience in cell culture and monoclonal antibody production; and experience in planning and conducting stability studies.
- Technical Knowledge: Immunological and biochemical techniques (ELISA, SDS-PAGE, Western blot). Methods for quantifying proteins and total nitrogen; conducting stability studies in accordance with ICH guidelines; managing documentation in a regulated environment (GMP/GLP); and experience with analytical data management software (preferred).
- Basic computer skills; advanced English (C1) and fluent German (B2) are preferred; and corporate competencies assessed as above average (preferred: 80th percentile).
Salary terms:
Based on the candidate’s profile, taking into account the industry and responsibilities of the position.
Notes:
We are looking for a creative and results-oriented technician with a firm yet empathetic leadership style, who is accustomed to building trusting relationships within their team and collaborating across departments.