CMC Biopharma Regulatory Consultant - Ecolab Life Sciences

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
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…
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