Clintec is currently looking to hire a variety of Scientific staff to work at our client's Biologics Analytical Department near Lucerne, Switzerland on a full time, permanent basis. This is an excellent opportunity for a scientists with strong technical background and hands-on experience in biochemical analytical methods to join our global organisation developing innovative biopharmaceuticals with state of the art technology. Apply now to become part of our diverse global team!
Our client's Biologics Analytical Department located in Switzerland is part of their global Bioprocess Development Division, working in this department the successful applicant will be part of a multidisciplinary team and support the development of novel biopharmaceuticals. As an active member of our global bioanalytical development team, you will work with your counterparts at our US research sites to apply state-of-the-art technology to support biotechnology process development. The integrated Biologics Analytical Department provides support to the Biotechnology Department by performing release and stability testing of biological drug substances and is responsible for global outsourcing of analytics for biologics, followed by study and quality monitoring to guarantee adherence to regulatory requirements and internal guidelines. Furthermore, the department conducts raw-/starting material and in-process testing for biological drug substances. The position offers development potential; responsibilities can be adjusted to the candidate’s qualifications and ambitions.
Main areas of responsibility include:
Performing cell-based assays and ELISAs for release, stability and recertification of biotech products.
Planning and implementation of analytical projects conducted both locally and in cooperation with international service providers.
Contributing to regulatory IND filings, BLA filings and the preparation of CTDs.
Preparing and executing analytical method transfers between a variety of CROs and company organizations including optimization and harmonization.
Reviewing and approving method validation plans and summaries.
Authoring of GMP documents: e.g. Analytical Methods, SOPs, Change Controls.
Implementation of new ELISA modalities and SPR methods is desirable.
Experience & Qualifications:
MSc. in Biochemistry/Biological Sciences.
Hands-on experience with ELISAs and/or cell-based assays. Fundamental technical understanding is required.
HPLC/UPCL or LC understanding
Protein biochemistry and/or biochemical analytical techniques of proteins or with any biophysical methods
Experience in project management and strong organizational skills.
Strong oral and written communication skills in English and German to at least C1 level
Work experience in a GMP environment and experience with analytical method validation and transfer is preferable.
Clintec is a dynamic, UK headquartered, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.