Senior Scientist Expert
18 ore fa
FIS is a leading Italian company and one of the top players in Europe in the development and production of Active Pharmaceutical Ingredients (APIs) for the global pharmaceutical industry. With three production plants and more than 2.300 employees, for almost 70 years we have focused on research, quality, and sustainability.FIS products improve the lives of millions of people: a responsibility we face with pride and passion. Join the team and become part of a company growing thanks to the commitment of those who live it every day. We are looking for a Expert in high-pressure chromatography with a strong background in peptide purification and process scale-up. The ideal candidate has several years of hands-on experience developing, optimizing, and implementing robust purification methods from R&D to large-scale, including GMP manufacturing environments. This role requires deep technical expertise, problem-solving ability, and the capacity to work cross-functionally with R&D, process development, manufacturing, and quality teams. Key Responsibilities Develop and optimize chromatographic purification methods for synthetic peptides using high-pressure systems (Reverse Phase-HPLC) and other ancillary technologies (Ion Exchange, Size Esclusion Chromatography); Scale purification processes from lab to pilot and production scale, ensuring robustness, reproducibility, and regulatory compliance; Select, configure, and validate chromatographic equipment, columns, resins, and system parameters; Design and execute experiments to evaluate critical process parameters and performance attributes; Troubleshoot complex purification challenges, including impurities, yield loss, peak splitting, column degradation, and pressure limitations; Implement process control strategies and participate in tech transfer to manufacturing; Support process characterization, validation, and documentation (SOPs, batch records, development reports); Work closely with analytical, upstream/solid-phase synthesis, and formulation teams to ensure seamless integration along the peptide production workflow; Stay current with emerging technologies and approaches in chromatography and peptide purification. Required Qualifications Advanced degree (PhD or MSc) in Chemistry, Analytical Chemistry, Industrial Chemistry, Chemical Engineering, or related disciplines; 5–10+ years of hands-on experience with high-pressure chromatography applied to peptide purification; Demonstrated expertise with method development, process optimization, and scale-up for preparative HPLC; Strong knowledge of column chemistry, stationary phases, pressure limits, and peptide behavior under chromatographic conditions; Experience in purification at pilot and manufacturing scale, ideally in a regulated environment (GMP preferred); Proficiency in chromatographic software and method modeling tools; Excellent troubleshooting, documentation, and communication skills; Knowledge of downstream unit operations beyond chromatography (ultrafiltration/diafiltration, lyophilization, crystallization). Preferred Experience Industrial experience in peptide therapeutics, CDMO, or specialty chemicals; Familiarity with continuous chromatography, simulated moving bed systems, or preparative UPLC. Key Competencies Strong technical leadership and ownership of purification workflows; Ability to design experiments and interpret complex data rapidly; Cross-functional collaboration and mentoring of junior scientists; Quality-minded, detail-oriented, and comfortable in a fast-paced environment. Office location FIS Head Quarters is located in Montecchio Maggiore (Vicenza).
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