Aufgabenbeschreibung / Overall objective
· Support of Lab Mangers and colleagues within SFB&O QC to assure analytical testing of drug products, intermediates, stability samples, raw materials and packaging materials, delivered to or manufactured within Site Biologics and Oncology Frankfurt (SFB&O). Analytical results are the basis for final release and batch disposition with respect to:
· Regulatory and legal requirements (AMG, AMWHV, GMP)
· Company processes and procedures
· Regulatory submissions
· Best scientific and technical practice (ICH, PhEur, USP, BP)
Verantwortlichkeiten / Tasks and Responsibilities
· Driving Projects within SFB&O QC to enhance and optimize performance and reliability utilizing standard LEAN techniques and MES tools
· Process optimization and standardization of work flows within SFB&O QC labs
· Assurance, Maintenance and Improvement of GMP status within QC labs
· Evaluation, verification of analytical results for drug products, intermediates and stability samples, raw materials and packaging materials
· Deputy Head Quality Control (German Drug Act, AMWHV §12 / §14)
· Assurance of complete, correct and timely testing of drug products, intermediates, stability samples, raw materials and packaging materials
· Assurance of the internal and external environmental health and safety requirements (HSE)
· Handling of laboratory events / exceptions like OOS, OOT, Deviations including root cause analysis and definition of CAPA
· Support of analytical method transfer, method optimizations and validation
· Representation of SFB&O QC internally and externally
· Coordination and communication with Third Party Labs, Third Party Manufacturer and Customers with respect to analytical testing
Anforderungen & Qualifikationen / Job requirements & Qualification
· University /FH degree in natural sciences like chemistry, biology, pharmaceutical sciences or equivalent degree or equivalent experience. PhD preferred but not mandatory.
· Experience and Knowledge in Regulatory and legal requirements of drug products (GMP, AMG, AMWHV)
· Experience and Knowledge in analytical sciences / pharmaceutical analytical sciences
· Leadership experience preferred,
· Knowledge in Standard Office tools and applications
· Experience in evaluation of analytical results and analytical test methods
· Experience in collaboration with internal / external and national / international colleagues
· Strong interdisciplinary collaboration skills and ability to work in a team
· Proactive and accurate work attitude
· Strong communication skills
· High engagement and willingness to use and enhance personal skills
· Foreign languages: English fluent
· An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
· An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
· An individual and well-structured introduction and training of new employees.
· You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
· As a globally successful and constantly growing company, Sanofi provides international career paths as well.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.