Cmc Biologics Analytical Principal Scientist
hace 6 días
Select how often (in days) to receive an alert:CMC Biologics Analytical Principal Scientist Mission Lead the analytical strategy for early/late programs.Day-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.Contribution to set up and development of in-house/outsourced analytical activitiesDefinition of DS & DP specification according to applicable regulatory guidelinesPrepare the plan for stability studies, reference standard, comparability studiesPrepare and/or review technical documents including method development, method validation, transfer protocols and reports.Authoring and review of CMC regulatory analytical submissions documentsWork closely with Drug Substance, Drug Product and Characterization Subject Matter Experts to develop analytical, characterization and comparability strategiesSupport defining/refining required processes for analytical/characterization activitiesExperience with analytical methods for GMP manufacturingUnderstanding of the detailed requirements for analytical validation and up to date with current trendsMight include CMC leadership activities.Education and Experience 15+ years of experience in the pharmaceutical industry focusing in analytical development.Experience in managing external and internal activities.Experience in data analysis and statistics.Experience with NBEs is preferred.Knowledge of GMP, GLP, GCP, Regulatory processes, a plus.Strong collaboration skills and experience working with external partnersCommunication skills in English written and oralValues Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.Courage: we challenge the status quo, we take full ownership and we learn from our success & failuresInnovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.Simplicity : we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.#J-18808-Ljbffr
-
Cmc Biologics Analytical Senior Scientist
hace 1 mes
Madrid, España Almirall Hermal Gmbh A tiempo completoSelect how often (in days) to receive an alert:CMC Biologics Analytical Senior Scientist Mission Day-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.Contribution to set up and development of in-house/outsource analytical activities.Definition of DS & DP...
-
Cmc Biologics Analytical Senior Scientist
hace 1 mes
Madrid, España Almirall Hermal Gmbh A tiempo completoSelect how often (in days) to receive an alert:CMC Biologics Analytical Senior ScientistMissionDay-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.Contribution to set up and development of in-house/outsource analytical activities.Definition of DS & DP specification...
-
CMC Biologics Senior Scientist Lead
hace 2 semanas
Madrid, Madrid, España Almirall Hermal Gmbh A tiempo completoJob DescriptionOverviewAlmirall Hermal Gmbh is seeking a highly skilled Senior Scientist to lead our analytical operations. As a key member of our team, you will be responsible for overseeing analytical activities performed at partnered CDMOs and CROs, ensuring compliance with industry standards and regulatory guidelines.ResponsibilitiesDay-to-day oversight...
-
Regulatory Manager
hace 4 meses
Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European...
-
Regulatory Manager
hace 7 meses
Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various...
-
Ra-Cmc Specialist
hace 1 mes
Madrid, España Galderma A tiempo completoWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
-
Data Scientist
hace 4 semanas
Madrid, Madrid, España Easypark Group A tiempo completo**Business Intelligence Expertise**We are seeking a skilled Data Scientist to help drive business growth through data-driven decision making.The ideal candidate will have a strong analytical background and be able to communicate complex ideas effectively.Key Responsibilities:Develop and maintain advanced data analytics modelsProvide data-driven insights to...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Galderma A tiempo completoGalderma is a pioneering dermatology company with a rich legacy and commitment to innovation. With operations in approximately 90 countries, we deliver a diverse portfolio of premium brands and services that cater to the evolving needs of the dermatology market.We are seeking an expert Regulatory Affairs CMC Specialist to join our team in Barcelona. As a key...
-
Principal Data Scientist
hace 6 meses
Madrid, España Geotab A tiempo completoWho we are: Geotab ® is a global leader in IoT and connected transportation and certified “Great Place to Work.” We are a company of diverse and talented individuals who work together to help businesses grow and succeed, and increase the safety and sustainability of our communities. Geotab is advancing security, connecting commercial vehicles to the...
-
Principal Data Scientist
hace 2 semanas
Madrid, Madrid, España Backbase Inc. A tiempo completoKey ResponsibilitiesAs a Principal Data Scientist, you will be responsible for developing, deploying, and maintaining machine learning models that solve business problems and drive product success. This involves designing and executing experiments, creating actionable insights through data analysis, leading the design of data pipelines to facilitate the...
-
Principal Scientist
hace 6 meses
Madrid, España The Wise Seeker Services A tiempo completoU.S. Silica's wholly-owned subsidiaries include EP Minerals and SandBox Logistics. EP Minerals is an industry leader in the production of products derived from diatomaceous earth, perlite, engineered clays and non-activated clays. SandBox Logistics is a state-of-the-art leader in proppant storage, handling and well-site delivery, and is dedicated to making...
-
Madrid, Madrid, España Parexel A tiempo completoParexel, a leading Clinical Research Organization (CRO), is committed to empowering our clients with exceptional consulting services. We are seeking an experienced Principal Regulatory Affairs Consultant (Associate Director level) to join our team. This role offers the opportunity to showcase your expertise in Chemistry, Manufacturing, and Controls (CMC) for...
-
R&d Senior Cmc Associate
hace 6 meses
Madrid, España Mabxience A tiempo completoOverview: **mAbxience i**s a global, vertically integrated fully-fledged **biotechnology company,** with over a decade of experience in the development, manufacture and commercialization of biopharmaceutical medicines. We incorporate the latest state-of-the-art technology in our development and manufacturing platform, across 3 multi product Drug Substance...
-
Data Scientist, Hibrido
hace 5 meses
Madrid, España Krell Consulting & Training A tiempo completoData Scientist en hibrido.País / Provincia España-Madrid Conocimiento clave Python Idiomas Inglés Alto Conocimientos imprescindibles Data Scientist Conocimiento avanzado en Python y Pyspark PostgreSQL y Power BI Base sólida de Estadística y Probabilidad necesaria para el reentreno y modelización del modelo ML.Así como los controles del Data Drift...
-
Analytical & Stability Hub Lead
hace 5 meses
Madrid, España Bayer A tiempo completo**ANALYTICAL HUB HEAD** **Main Purpose** The Global Analytical & Stability Hub Lead is responsible for fostering a culture of collaboration, empowerment, and shared accountability within the Analytical Development and Stability Hubs across the entire BCH enterprise. This role plays a critical part in ensuring the quality and compliance of analytical...
-
Laboratory Scientist
hace 2 semanas
Madrid, Madrid, España Laboratorios Medicamentos Internacionales S.A A tiempo completoJob Title: Laboratory ScientistJob Description:We are seeking a skilled Laboratory Scientist to join our team at Laboratorios Medicamentos Internacionales S.A. The ideal candidate will have a strong background in analysis and control laboratory, with experience in operating Waters and Agilent HPLC systems and UPLC with Empower software.Key...
-
Data Scientist, Hibrido
hace 3 días
Madrid, España Krell Consulting & Training A tiempo completoData Scientist País / Provincia España-Madrid Conocimiento clave Python Idiomas Inglés Alto Conocimientos imprescindibles Data Scientist Conocimiento avanzado en Python y Pyspark PostgreSQL y Power BI Base sólida de Estadística y Probabilidad necesaria para el reentreno y modelización del modelo ML.Así como los controles del Data Drift Detection...
-
Data Scientist
hace 6 meses
Madrid, España SG Tech A tiempo completoDescripción ¡Hola! Somos SG Tech, una empresa líder en el sector tecnológico especializada en soluciones de análisis y procesamiento de datos. Actualmente estamos en búsqueda de un/a **Data Scientist** para formar parte de nuestro equipo. **Información del puesto**: - Empresa: SG Tech - Posición: Data Scientist - Experiência requerida: 2 años -...
-
Senior Data Scientist
hace 4 semanas
Madrid, Madrid, España Almirall Hermal Gmbh A tiempo completoRole OverviewThe Data Office team at Almirall Hermal Gmbh is dedicated to driving a culture of evidence-based decision making across the organization. As a key member of this team, the Senior Data Scientist will play a pivotal role in developing advanced analytical solutions that drive business growth.
-
Principal Applied Scientist, Shopping Discovery
hace 3 semanas
Madrid, España Amazon A tiempo completo.Principal Applied Scientist, Shopping Discovery & EvaluationAs a Principal Applied Scientist, you are a trusted part of the technical leadership. You bring business and industry context to science and technology decisions. You set the standard for scientific excellence and make decisions that affect the way we build and integrate algorithms. You solicit...