CMC Biopharma Regulatory Consultant — Life Sciences

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, and commercial teams to develop scalable Biopharma offerings.

• Bachelor of Science degree or equivalent in Life Sciences, Biochemistry, Biotechnology, Chemical Engineering, Bioprocess Engineering, or a related discipline.
• Experience in Biopharma manufacturing, process development, MSAT, purification sciences, technical service, quality, regulatory affairs, or a related customer-facing technical role.
• Strong understanding of downstream purification processes, especially chromatography applications used in biologics manufacturing.
• Experience troubleshooting technical challenges, supporting investigations, evaluating process performance data, and developing practical corrective or improvement actions.
• Experience designing and delivering technical training or customer-facing technical presentations.
• Strong understanding of GMP, quality systems, change control, validation principles, and regulatory expectations for Biopharma manufacturing.
• Excellent oral and written communication skills, analytical thinking, customer discovery, problem solving, and stakeholder influencing skills.
• Ability to travel 50%+ of time in region, potentially at short notice.
• Ability to travel globally periodically.
• Clean driver’s license and ability to apply for travel visas.
• Fluent in English.

• Master’s degree or PhD in Life Sciences, Biochemistry, Biotechnology, Chemical Engineering, Bioprocess Engineering, or a related discipline.
• Hands‑on experience with Protein A chromatography, affinity chromatography, ion exchange chromatography, resin lifetime studies, column packing, CIP optimization, or downstream purification troubleshooting.
• Knowledge of change control, comparability, post‑approval change management, and regulatory filing strategies for…