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 Ecolabs 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 Ecolabs 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 youll make an impact:

• Provide technical consulting services that leverage Ecolabs 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 Ecolabs 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 drivers license and ability to apply for travel visas.
• Fluent in English.

Additional Qualifications:

• Masters 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 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).