CMC Biopharma Regulatory Consultant - Ecolab Life Sciences

04 ago - Roma
Experteer Italy

h3CMC Biopharma Regulatory Consultant - Ecolab Life Sciences /h3pIn this role you apply deep technical expertise in chromatography and biopharma purification to support adoption of Ecolab’s resin and purification solutions. You work across commercial, regulatory, RD, and field teams to translate customer needs into value, driving resin conversions and process improvements. You’ll engage with customers on methodology, validation, and regulatory strategies while helping de-risk change and ensure quality and supply security. This position offers a chance to shape Biopharma purification programs at scale in Europe and beyond. /pulliProvide customer-facing technical consulting on downstream purification and resin performance /liliAct as pre-sales expert to support Biopharma opportunities with resin conversion and process optimization /liliCollaborate with customers at their sites to improve purification performance, product quality, and efficiency /liliAdvise on resin evaluation, comparability, validation activities and regulatory filing strategy /liliContribute to customer change control by delivering technical documentation and risk assessments /liliBuild relationships with Process Development, MSAT, Manufacturing, Quality, Regulatory Affairs, Procurement, and CDMOs /liliArticulate value of purification solutions focusing on total cost of ownership and regulatory de-risking /liliRepresent the company at meetings, forums,



webinars, and conferences to strengthen credibility /liliSupport product, service, and digital innovation by capturing customer pain points and partnering on scalable offerings /liliBachelor of Science degree or equivalent in Life Sciences, Biochemistry, Biotechnology, Chemical Engineering, Bioprocess Engineering, or related discipline /liliExperience in Biopharma manufacturing, process development, MSAT, purification sciences, technical service, quality, regulatory affairs, or related customer-facing role /liliStrong understanding of downstream purification processes, especially chromatography in biologics manufacturing /liliExperience troubleshooting, investigations, data analysis, and implementing corrective actions /liliExperience designing and delivering technical training or customer-facing presentations /liliStrong GMP knowledge, change control, validation principles, and regulatory expectations for Biopharma /liliExcellent communication, analytical thinking, customer discovery, problem solving, and stakeholder influencing skills /liliAbility to travel 50%+ regionally and globally; valid driver’s license; travel visas as needed /li /ulIn this role you apply deep technical expertise in chromatography and biopharma purification to support adoption of Ecolab’s resin and purif… #J-18808-Ljbffr

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