Buscar empleo: 156 ofertas de trabajo de sur en Canyelles (agosto 2026)

CMC Biopharma Regulatory Consultant — Ecolab Life Sciences

hace 14 días

Barcelona

• 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 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 At 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. Ecolab’s commitment to diversity, equity and inclusion (DE&I) reflects our longstanding value of working together to integrate diverse perspectives to challenge ourselves, reach our goals and do what’s right. 7 425,00 • Ecolab strives to provide comprehensive and market‑competitive benefits to meet the needs of our associates and their families. In Italy, Ecolab applies the National Collective Labour Agreement for the Chemical Industry (CCNL Industria Chimica). Ecolab 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. Nous 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. Ecolab 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. #J-18808-Ljbffr

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