Cmc Biologics Analytical Senior Scientist
hace 2 meses
Select 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 according to applicable regulatory guidelines.Prepare the plan for stability studies, reference standard, comparability studies.Prepare and/or review technical documents including method development, method validation, transfer protocols and reports.Authoring and review of CMC regulatory analytical submissions documents.Work closely with Drug Substance, Drug Product and Characterization Subject Matter Experts to develop analytical, characterization and comparability strategies.Support defining/refining required processes for analytical/characterization activities.Experience with analytical methods for GMP manufacturing.Understanding of the detailed requirements for analytical validation and up to date with current trends.Might include CMC leadership activities.Education and ExperienceMaster degree or PhD in relevant scientific area or equivalent.Experience with chromatographic and pharmacopeia methods for biologics.Experience in establishing specifications.Experience in preparing and reviewing relevant filing documentation for regulatory applications specially for early phase.Experience with NBEs is preferred.Knowledge of GMP, GLP, GCP, Regulatory processes, a plus.Strong collaboration skills and experience working with external partners.Communication skills in English written and oral.Analytical skills.Prioritization and Organization skills.ValuesCare: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 & failures.Innovation: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 2 meses
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 Principal Scientist
hace 2 semanas
Madrid, España Almirall Hermal Gmbh A tiempo completoSelect 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...
-
CMC Biologics Senior Scientist Lead
hace 3 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 5 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 8 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...
-
Regulatory Manager
hace 1 día
Madrid, España Parexel International A tiempo completoAre 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 locations. As the CMC Regulatory Manager, you will play a vital...
-
Regulatory Manager
hace 1 día
Madrid, España Parexel International A tiempo completoAre 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 locations.As the CMC Regulatory Manager, you will play a vital role...
-
Ra-Cmc Specialist
hace 2 meses
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...
-
Senior Global CMC Strategy Manager
hace 3 semanas
Madrid, Madrid, España TFS HealthScience A tiempo completoCompetitive compensation for your expertise and contributions, estimated at $120,000 - $180,000 per year, depending on experience and qualifications. Opportunity to lead high-impact global projects in a collaborative environment. Flexibility to work remotely, offering a healthy work-life balance. A chance to work with a global organization committed to...
-
Senior Data Scientist
hace 1 mes
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.
-
Senior Regulatory Affairs Manager
hace 3 meses
Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve.We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise.This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global...
-
Senior Regulatory Affairs Manager
hace 3 meses
Madrid, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies...
-
Senior Data Scientist
hace 1 mes
Madrid, Madrid, España Basf Digital Solutions A tiempo completoAbout UsBASF Digital Hub Madrid is a hub for innovation and digital solutions. We develop cutting-edge digital solutions for BASF, create new customer experiences, and drive business growth. Our team believes in creativity, trial and error, and collaboration to achieve success. We are looking for a Senior Data Scientist to join our team and contribute to our...
-
Data Scientist
hace 1 mes
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...
-
Senior Bioinformatics Scientist
hace 4 meses
Madrid, España Sebibc A tiempo completo.We are hiring a Senior Bioinformatics Scientist at the Carlos Simon FoundationAre you an experienced Bioinformatician with a drive to impact the lives of patients worldwide? Would you like to apply your bioinformatics and data science expertise to some of the most pressing issues in women's health? Here, at the Carlos Simon Foundation, we are positioned at...
-
Regulatory Affairs Specialist
hace 3 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...
-
Senior Data Scientist
hace 6 meses
Madrid, España Next Ventures Limited A tiempo completoPractice **Data** - Technologies **Business Intelligence Jobs and Data Recruitment** - Location **Madrid, Spain** - Type **Contract** **FREELANCE SENIOR DATA SCIENTIST REQUIREMENT** **MADRID BASED & SPANISH SPEAKING** **LEADING CONSTRUCTION CUSTOMER WITH HYBRID WORKING** **6-12 MONTH INITIAL ENGAGEMENT** Good Afternoon Network, Happy Monday! I hope...
-
Immunology Scientist
hace 5 días
Madrid, España Kymos Group A tiempo completoKYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany and a Liasson office in South Korea, offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have...
-
Junior Manager Regulatory Affairs Cmc
hace 2 meses
Madrid, España Mabxience A tiempo completoOverview:The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes.The position supports and promotes all regulatory CMC tasks throughout the...
-
Junior Manager Regulatory Affairs Cmc
hace 2 meses
Madrid, España Mabxience A tiempo completoOverview: The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes. The position supports and promotes all regulatory CMC tasks throughout...