Hoffmann-La Roche. Basel , 29.11.
Who we are
At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
The headquarters in Basel is one of Roche's largest sites, over 8,000 people from approximately 80 countries work at Roche Basel. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland − a great place to live and work.
In a regulated bioanalysis environment, act as Bioanalytical leader to deliver high quality and timely bioanalytical strategies, data and reports to non-clinical and clinical project teams. Interact with CROs for conducting required bioanalytical work.
Your responsibilities are:
- Manage full bioanalytical support for assigned multiple projects by providing support to internal project teams and directing bioanalytical work at CROs
- Ensure the transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies and any concomitant/interaction compound in the given project.
- Manage and direct analysis of samples and timelines from preclinical, tox and clinical studies for the project at CRO labs and participate actively in DMPK and clinical subteams
- Review protocols and guide project teams in all aspects of bioanalytical work required for the project, including the interpretation of immunogenicity data
- Ensure full compliance with the current global and local bioanalytical regulatory guidances and GxPs
- Leadership in Bioanalysis: Remain current and continually develop expertise in bioanalytical science of large molecules, including immunogenicity testing
- Guide and manage the bioanalysis of large molecules at CROs, including immunogenicity testing, and ensure that most advanced and most efficient procedures are used
- Review and write reports for regulatory submissions; support filings and answer any questions coming from the regulatory agencies as well as reports to the Head of Large Molecule Regulated Bioanalytics
Who are you
You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
- Doctorate degree or equivalent with strong background in analytical chemistry of large molecules (at least 5 years of experience in a Bioanalytical or DMPK department of a Pharma company)
- Demonstrated experience in the area of bioanalytics of large molecule drugs (ELISA) including immunogenicity testing and CRO monitoring
- Sound knowledge of the regulatory environment specific to bioanalytical work and commitment to maintain high quality of delivered data, compliance and scientific quality, optimal use of resources
- Recent and relevant work in a Pharma company lab or outsourcing function where regulated bioanalysis is run according to the FDA and EMA guidelines
- Excellent communication skills and ability to work in a matrix organization
- Strong people skills; ability to represent function and provide leadership in a multidisciplinary project team
- Self-motivation, ability to work independently in a matrix organization, goal setting, sense of responsibility, team player, attention to details, interest in continuing improvements, ability to focus and prioritize, communication
- Very good knowledge of English (spoken and written) and excellent knowledge of computer applications
The next step is yours. Please apply online.
Roche is an Equal Opportunity Employer