CMC Biopharma Regulatory Consultant — Ecolab Life Sciences

Ecolab is the global leader in water, hygiene and energy technologies and services that provide clean water, safe food, abundant energy and healthy environments. We deliver comprehensive programs and services to the food, energy, healthcare, industrial and hospitality markets in more than 160 countries.

Ecolab Life Sciences is committed to accelerating growth in Biopharma by helping customers solve complex purification, process optimization, and regulatory change challenges. The Biopharma Technical Consultant role is a key enabler of this strategy, bringing deep technical expertise, customer insight, and influence to support adoption of Ecolab chromatography resin and purification solutions.

The Biopharma Technical Consultant will provide customer-facing technical consulting for downstream purification, chromatography resin performance, resin conversion, comparability strategy, and regulatory change management. This role works closely with commercial, regulatory, R&D, application laboratory, and field teams to create customer value, support business conversion, and strengthen Ecolab’s position as a trusted technical partner in Biopharma.

This role will be based in EUROPE with a requirement to travel to regional and international Biopharma customer sites as needed.

The Biopharma Technical Consultant is responsible for providing expert technical and regulatory consulting to support the use, evaluation, and conversion of Ecolab chromatography resin and purification solutions in Biopharma manufacturing. The role advises customers on resin performance, downstream purification process optimization, comparability considerations, validation approaches, and post-approval change strategies, including alignment with relevant regulatory expectations such as ICH Q5E, ICH Q12, and regional variation requirements.

The role provides a critical link between customer technical teams and Ecolab’s internal commercial, regulatory, marketing, R&D, and application laboratory teams. It supports business growth by translating customer purification and regulatory challenges into value-based solutions, identifying compelling events for resin adoption, and helping customers de-risk change while improving quality, efficiency, supply security, and total cost of ownership.

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.

Qualifications:

• 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.

Additional Qualifications:

• 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 biologics.
• Strong knowledge of ICH Q5E, ICH Q8, ICH Q9, ICH Q10, ICH Q12, GMP expectations, FDA post-approval change pathways, EMA variation requirements, or other regional Biopharma regulatory frameworks.
• Experience working with monoclonal antibodies, biosimilars, CDMOs, or large-scale biologics manufacturing environments.
• Ability to build business cases and value stories that connect technical performance, regulatory risk reduction, supply security, and total cost of ownership.
• Demonstrated ability to influence senior technical, quality, regulatory, and commercial stakeholders in complex customer environments.
• Experience presenting at industry conferences, customer technical forums, webinars, or professional associations such as ISPE, PDA, CASSS, or BIO.
• Ability to take initiative, work independently, prioritize multiple projects, and deliver with strong follow-through.
• Flexibility to manage multiple customer, commercial, and innovation projects at the same time while meeting deadlines.

• Knowledge of regional regulatory frameworks e.g., FDA, EMA, MHRA, NMPA, PMDA, Health Canada, TGA].

No immigration or relocation sponsorship available for this opportunity

Compensation Range:

Benefits:

Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families. Click here to see our benefits. 

Collective Agreement Information (Italy):

In Italy, Ecolab applies the National Collective Labour Agreement for the Chemical Industry (CCNL Industria Chimica).