CMC Biopharma Regulatory Consultant

13 ago - Roma
Experteer Italy

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 chromatograph

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