CMC Biopharma Regulatory Consultant - Ecolab Life Sciences
Pubblicato il 06-08-2026 - Experteer Italy in Roma
CMC Biopharma Regulatory Consultant - Ecolab Life Sciences In 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, R&D;, 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.
- Provide customer-facing technical consulting on downstream purification and resin performance
- Act as pre-sales expert to support Biopharma opportunities with resin conversion and process optimization
- Collaborate with customers at their sites to improve purification performance, product quality, and efficiency
- Advise on resin evaluation, comparability, validation activities and regulatory filing strategy
- Contribute to customer change control by delivering technical documentation and risk assessments
- Build relationships with Process Development, MSAT, Manufacturing, Quality, Regulatory Affairs, Procurement, and CDMOs
- Articulate value of purification solutions focusing on total cost of ownership and regulatory de-risking
- Represent the company at meetings,
forums, webinars, and conferences to strengthen credibility
- Support product, service, and digital innovation by capturing customer pain points and partnering on scalable offerings
- Bachelor of Science degree or equivalent in Life Sciences, Biochemistry, Biotechnology, Chemical Engineering, Bioprocess Engineering, or related discipline
- Experience in Biopharma manufacturing, process development, MSAT, purification sciences, technical service, quality, regulatory affairs, or related customer-facing role
- Strong understanding of downstream purification processes, especially chromatography in biologics manufacturing
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- Experience troubleshooting, investigations, data analysis, and implementing corrective actions
- Experience designing and delivering technical training or customer-facing presentations
- Strong GMP knowledge, change control, validation principles, and regulatory expectations for Biopharma
- Excellent communication, analytical thinking, customer discovery, problem solving, and stakeholder influencing skills
- Ability to travel 50%+ regionally and globally; valid driver's license; travel visas as needed
In this role you apply deep technical expertise in chromatography and biopharma purification to support adoption of Ecolab's resin and purif...