Quality Control Laboratory Technician
We are a Contract Development and Manufacturing Organization (CDMO) with over 40 biotech companies worldwide that have placed their trust in us. We develop and manufacture lentiviral vectors as a European leader working under both EMA and FDA standards. The lentiviral vectors produced by VIVEbiotech are used to treat a range of disorders, including haematological and solid cancers, and rare diseases.
We are looking for you to be part of our Team!
We are looking for a talented and highly motivated Quality Control Laboratory Technician, to perform a key position reporting directly to the Quality Control Responsible, with experience in analytical laboratories in the pharmaceutical industry or in life science or pharmaceutical related fields as well as proven experience and expertise in assay development.
Hands-on experience in multiple cell-based analytical techniques and methods (e.g., flow cytometry, qPCR, ELISAS, or others) is required.
You will execute routine or specialized tests, as needed, to support the manufacture and, release of lentiviral products manufactured under GMP conditions.
You will perform assays required to respond to stability studies for each lentiviral product generated.
You will coordinate and advise with the production department (USP/DSP), the implementation of analytical techniques for the analysis of the different samples generated during the production process, including sample transfer and follow-up of results.
- You will execute the analytical assays currently implemented in VIVEbiotech to characterize gene therapy products. These techniques will involve ELISA, flow cytometry and qPCR based techniques, among others.
- You will perform mammalian cell cultures and analytical tests based on molecular biology (Infections, viability assays etc.).
- You will work under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) conditions.
- You will adequately inform the team leader of the results obtained respecting the established reporting times and necessary records.
- You will write, edit and review documents, including but not limited to SOPs, reports and material or equipment specifications.
- You will perform periodic maintenance and qualification of laboratory equipment.
- You will participate in routine environmental control sampling and sample collection during the manufacture of lentiviral products generated in a classified area.
- You will support laboratory management activities, cleaning, sample organization, and safety in accordance with corporate standards.
- You will work closely with the USP / DSP Production group assisting in the implementation of appropriate analytical techniques and managing the transfer of samples between both departments for analysis.
- You will work with external service providers and DEMO management for an implementation of new technologies at VIVEbiotech.
- University or Higher Degree studies related to Molecular Biology, Biotechnology, Biomedicine, Pharmacy, etc.
- You have experience in analytical laboratories, preferably in the pharmaceutical industry, and have practiced multiple cell-based analytical techniques and methods, such as flow cytometry, qPCR, and ELISAS, among others.
- You have knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- You have excellent data management skills with Excel and are fluent in other Microsoft Office tools.
- You have a knowledge of English equivalent to level B2 (First Certificate of English).
- You have high ability to manage and work effectively within a team, with leadership.
- You demonstrate excellent organizational, interpersonal and problem solving skills.
- You are comfortable and resilient in a changing environment and able to adjust workload based on changing priorities.
- You are able to work quickly and accurately with a strong focus on detail, in a rigorous manner.
- You are always high quality oriented (excellence and self-demanding) and demonstrate autonomy.
- You are able to work under pressure of results and deadlines, with proactivity and responsibility.
- You like to work with a positive attitude towards change.
- You possess good oral and written communication skills.
We offer you
- You will have continuous career development that will help you develop your talent throughout your entire professional career.
- You will participate in innovative projects in constant technological update.
- You will have a competitive salary according to your profile for this position.
- You will have a flexible timetable, with the support you need to conciliate and balance your personal and professional life.
- You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to go ahead in the cure of diseases.
- We will support you in your personal change process, if you come from another region and wish to come to live in Donostia-San Sebastián (accommodation, support in the job placement for members of your family unit, schooling…).
- You will enjoy a professional work environment, which is really distinguished by our humanity and closeness. And where we take care of diversity and inclusion. Diverse viewpoints, your curiosity, bring diverse capabilities that strengthen our focus and fuel our growth.
- We are proud on offering equal opportunities and a close, welcoming environment. All people receive consideration for our vacant positions, without distinction of gender, age, race, religion, identity, sexual orientation, origin, disability or any other characteristic.