Analytical Development Technician

About us

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!

Your role

We are looking for an Analytical Development Technician for a key position in our Quality Control department, with previous experience working in a molecular biology or bioassay laboratory (ELISA, qPCR and/or Immunoassays), and experience in scientific writing, keeping up to date with professional knowledge and best practices.

You will maintain close collaboration with the QC department to provide support, mentoring and technology transfer of analytical techniques developed in-house.

You will work closely with the USP / DSP team assisting them in the implementation of appropriate analytical techniques and managing the transfer of samples to the QC team for analysis.

Your responsibilities

• You will perform the necessary assays to optimize the analytical methods required for the correct characterization of lentiviral products.
• You will perform 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 participate in the experimental design and strategies to improve VIVEBiotech’s current analytical methods.
• You will document analytical method development activities in laboratory notebooks (including electronic log) and analytical method development reports to support regulatory documentation.
• You will perform mammalian cell culture and molecular biology based analytical testing (Infections, viability assays etc.).
• You will work under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) conditions.
• You will adequately report results obtained to the team leader according to established reporting times and necessary records.
• You will write, edit and review documents including but not limited to standard operating procedures (SOPs), reports and material or equipment specifications.
• You will support laboratory management activities, cleaning and sample organization.
• You will respect the company’s safety standards and collaborate in their continuous improvement by reporting incidents both in your own area and in the rest of the company if they are detected.
• You will work with external service providers.
• You will remain permanently updated in the appropriate knowledge for the development and evolution of your function.
• You will proactively provide ideas for continuous improvement of cost or efficiency related to your job in order to collaborate in the achievement of the objectives of your entire department.
• You will be an example of the company culture based on values of teamwork, customer orientation and continuous improvement in quality, safety and environment.
• You will report to your direct manager any significant incident that has an impact on the smooth running of your activity or the activity of your team or section.

About you

• University and Master studies related to Molecular Biology, Biotechnology, Biomedicine, Pharmacy, etc.
• You have previous experience working in molecular biology or bioassay laboratory (ELISA, qPCR and/or Immunoassays).
• Experienced in scientific writing, you keep up to date with professional knowledge, experience and best practices.
• You possess excellent data management skills with Excel and are fluent in other Microsoft Office tools.
• You have a knowledge of English equivalent to B2 level (First Certificate of English).
• You have a high capacity to manage and work effectively within a team, with leadership.
• You demonstrate excellent organizational, interpersonal and problem solving skills.
• You have a high capacity for continuous learning, always with a vision of continuous process improvement.
• 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.