CMC Biopharma Regulatory Consultant — Ecolab Life Sciences (Barcelona)

CMC Biopharma Regulatory Consultant — Ecolab Life Sciences (Barcelona)

04 ago
|
Ecolab
|
Barcelona

04 ago

Ecolab

Barcelona

ph3How You'll Make An Impact /h3ulliProvide 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. /liliAct 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. /liliWork 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. /liliSupport 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. /liliSupport customer change control processes by contributing technical documentation, risk assessments, validation rationale, training material, and regulatory change packages in a timely and accurate manner. /liliBuild trusted relationships with technical and regulatory decision makers, including Process Development, MSAT, Manufacturing, Quality, Regulatory Affairs, Procurement, and CDMO stakeholders. /liliUse 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. /liliServe 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. /liliSupport product, service, and digital innovation by capturing customer pain points, identifying compelling events such as supply disruptions or patent cliffs, and partnering with marketing, RD, regulatory, and commercial teams to develop scalable Biopharma offerings. /li /ulh3Qualifications /h3ulliBachelor of Science degree or equivalent in Life Sciences, Biochemistry, Biotechnology, Chemical Engineering, Bioprocess Engineering, or a related discipline. /liliExperience in Biopharma manufacturing, process development, MSAT, purification sciences, technical service, quality, regulatory affairs, or a related customer-facing technical role. /liliStrong understanding of downstream purification processes, especially chromatography applications used in biologics manufacturing. /liliExperience troubleshooting technical challenges, supporting investigations, evaluating process performance data,



and developing practical corrective or improvement actions. /liliExperience designing and delivering technical training or customer-facing technical presentations. /liliStrong understanding of GMP, quality systems, change control, validation principles, and regulatory expectations for Biopharma manufacturing. /liliExcellent oral and written communication skills, analytical thinking, customer discovery, problem solving, and stakeholder influencing skills. /liliAbility to travel 50%+ of time in region, potentially at short notice. /liliAbility to travel globally periodically. /liliClean driver’s license and ability to apply for travel visas. /liliFluent in English. /li /ulh3Additional Qualifications /h3ulliMaster’s degree or PhD in Life Sciences, Biochemistry, Biotechnology, Chemical Engineering, Bioprocess Engineering, or a related discipline. /liliHands‑on experience with Protein A chromatography, affinity chromatography, ion exchange chromatography, resin lifetime studies, column packing, CIP optimization, or downstream purification troubleshooting. /liliKnowledge of change control, comparability, post‑approval change management, and regulatory filing strategies for biologics. /liliStrong 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. /liliExperience working with monoclonal antibodies, biosimilars, CDMOs, or large‑scale biologics manufacturing environments. /liliAbility to build business cases and value stories that connect technical performance, regulatory risk reduction, supply security, and total cost of ownership. /liliDemonstrated ability to influence senior technical, quality, regulatory, and commercial stakeholders in complex customer environments. /liliExperience presenting at industry conferences, customer technical forums, webinars, or professional associations such as ISPE, PDA, CASSS, or BIO. /liliAbility to take initiative, work independently, prioritize multiple projects, and deliver with strong follow‑through. /liliFlexibility to manage multiple customer, commercial, and innovation projects at the same time while meeting deadlines. /liliKnowledge of regional regulatory frameworks e.g., FDA, EMA,



MHRA, NMPA, PMDA, Health Canada, TGA. /li /ulpNo immigration or relocation sponsorship available for this opportunity /ph3About Ecolab /h3pAt Ecolab, we prioritize our talent‑first philosophy by creating the most capable and diverse team to excel at our nearly three million customer sites. Building on a century of innovation, our 48,000 associates help deliver comprehensive science‑based solutions, data‑driven insights and world‑class service to advance food safety, maintain clean and safe environments, and optimize water and energy use, and improve operational efficiencies and sustainability for customers in the food, healthcare, life sciences, hospitality and industrial markets in more than 170 countries around the world. Our solutions not only enhance operational efficiency but also contribute to sustainability and public health, making a positive impact on the world. We are committed to eliminating unnecessary complexities and embracing a beginner's mindset, continuously seeking new perspectives and innovative solutions to stay ahead in a rapidly changing world. /ppEcolab’s commitment to diversity, equity and inclusion (DEI) reflects our longstanding value of working together to integrate diverse perspectives to challenge ourselves, reach our goals and do what’s right. /ph3Compensation Range /h3p7 425,00 /ph3Join Ecolab and help us protect what’s vital. /h3h3Benefits /h3ulliEcolab strives to provide comprehensive and market‑competitive benefits to meet the needs of our associates and their families. /li /ulh3Collective Agreement Information (Italy) /h3pIn Italy, Ecolab applies the National Collective Labour Agreement for the Chemical Industry (CCNL Industria Chimica). /ph3Notre engagement envers une culture d'inclusion et d'appartenance /h3pEcolab s'engage à traiter de manière juste et équitable ses collaborateurs ainsi que tous les candidats, tout en promouvant le principe d´égalité des chances dans l'emploi. /ppNous recruterons, embaucherons, promouvrons, transférerons et offrirons sur tous les sujets (avancement dans l´entreprise, rémunération, avantages sociaux, conditions de travail etc.) des possibilités d´évolution en fonction des qualifications individuelles et des résultats de chacun. /ppEcolab ne fera aucune discrimination à l'encontre d'un associé ou d'un candidat en raison de son origine, de sa religion, de sa couleur, de sa croyance, de son sexe, de son orientation sexuelle, de son identité et de son expression de genre, des informations génétiques, de son état matrimonial, de son âge ou de son handicap. /p /p #J-18808-Ljbffr

📌 CMC Biopharma Regulatory Consultant — Ecolab Life Sciences (Barcelona)
🏢 Ecolab
📍 Barcelona

Postulate a este anuncio

Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: cmc biopharma regulatory consultant — ecolab life sciences (barcelona) / barcelona

Suscribete a esta alerta:

Recibe por email las nuevas ofertas de trabajo para: cmc biopharma regulatory consultant — ecolab life sciences (barcelona) / barcelona