CMC Biopharma Regulatory Consultant — Ecolab Life Sciences

12 ago - Roma
Ecolab

How You'll Make An Impact
- Provide technical consulting services that leverage Ecolab’s expertise in chromatography resin performance, downstream purification, and regulatory change management to help commercial teams understand customer needs and increase account revenue.
- Act as a pre-sales and customer-facing technical expert for Biopharma opportunities, especially where resin conversion, process optimization, supply security, or regulatory change complexity are key decision drivers.
- Work alongside customers at their facilities to identify opportunities to improve purification performance, product quality, operational efficiency, resin lifetime, and risk mitigation while maintaining regulatory compliance.
- Support or manage customer resin evaluation, comparability, and validation activities by advising on methodology, experimental design, small-scale model qualification, accelerated resin aging studies, and regulatory filing strategy.
- Support customer change control processes by contributing technical documentation, risk assessments, validation rationale,



training material, and regulatory change packages in a timely and accurate manner.
- Build trusted relationships with technical and regulatory decision makers, including Process Development, MSAT, Manufacturing, Quality, Regulatory Affairs, Procurement, and CDMO stakeholders.
- Use data, customer insight, and business acumen to articulate the value of Ecolab purification solutions, including total cost of ownership, process robustness, supply continuity, and regulatory change de-risking.
- Serve as an internal and external subject matter expert by presenting at customer meetings, technical forums, industry events, webinars, and conferences to strengthen Ecolab’s credibility in Biopharma purification.
- Support product, service, and digital innovation by capturing customer pain points, identifying compelling events such as supply disruptions or patent cliffs, and partnering with marketing, R&D;, regulatory,

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