Analytical Development Scientist
We are a Contract Development and Manufacturing Organization (CDMO) with over 20 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 Analytical Development Scientist with experience in analytical development and analytical validation methods.
You will participate in the development, optimization, and validation of analytical techniques for the characterization of gene therapy products.
You will ensure the analytical assays will have enough robustness for transfer to a QC laboratory environment for clinical manufacture application.
You should have experience working in analytical laboratory with a high standard of quality and good knowledge in Good Laboratory Practice.
You will execute the analytical assays currently implemented at VIVEBiotech to characterize the gene therapy products. These techniques will principally involve ELISA, Flow Cytometry and qPCR-based techniques.
You will contribute to the design and implementation of experimental strategies to improve the current analytical methods.
You will participate in the setting up, optimization, and validation of analytical assays for the characterization of gene therapy products.
You will document analytical method development activities in laboratory notebooks (including electronic register) and analytical method development reports to support regulatory documentation.
You will manage the production of SOP’s and protocols to corporate quality standards as required.
You will understand the process development workflows (USP/DSP) and implement suitable analytical assays to evaluate the performance of the processes.
You will assist and execute the analytical method transfer to the Quality Control group.
You will coordinate with the Quality Control group the qualification/validation of all analytical assays.
You will participate in the evaluation and potential implementation of cutting-edge technologies to improve the characterization of gene therapy products.
You will act as “super user” for appropriate equipment and provide training to other staff members from the Development laboratories as required.
You will support laboratory management activities and contribute to housekeeping and safety according to corporate standards.
You will disseminate analytical development work internally and externally where appropriate
You will work with external service providers.
You are who we are looking for if you have:
- Bachelor Degree in Molecular Biology, Biotechnology, Biomedicine, Pharmacy,…
- Desirable: Ph.D.s
- Excellent written and oral communication in English.
- Essential MSc with 3+ years industrial experience within an appropriate Life Science environment
- Proven experience and expertise in assay development. Hands-on in multiple cell-based analytical techniques and methods is required (e.g. flow-cytometry, qPCR, chemometrics, others).
- Experience in scientific writing, keeps up to date with professional knowledge, expertise and best practice.
- Knowledge of ICH Guidelines for analytical assays is strongly desirable (ICH Q2 R1).
- Awareness of Quality Assurance and Good Manufacturing Practices is a plus.
- Ability to manage and work effectively within a team. Be a team player.
- Excellent organizational, interpersonal, and problem-solving skills.
- Comfortable and resilient to adjust workload based upon changing priorities.
- Ability to work quickly and accurately with a strong focus on detail, takes initiative when required.
- Excellent IT skills in MS Excel and other MS office tools (Word, PowerPoint)
- Experience in bioinformatics is desirable.
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.