Cmc Biologics Analytical Senior Scientist
hace 1 mes
Date: 15 Oct 2024
Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain
Company: Almirall
Mission The Biologics Development department in Almirall is growing and we are looking for a Analytical Lead/Scientist that is going to help us bring the best innovative biopharmaceuticals to patients and will join the team in our R&D center in Barcelona
Our biologics pipeline is growing, and we need your competences to secure our end goals are meet.
As our Biologics Analytical Lead, you will be an instrumental team member of the Biologics Development group. The primary roles of this position are to lead all topics related to Analytics (method development, comparability studies, etc) in CDMOs as well as driving the GMP QC activities of antibody-based molecules. We are looking for someone with hands-on experience in analytical development and QC knowledge and that is willing to grow with the company.
You will work in close collaboration with colleagues across the organization, as a member in our multidisciplinary project teams and in close contact with our network of global Contract Development Manufacturing Organizations (CDMOs).
Tasks and Responsabilities 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/outsorced 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 Experience Master 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. Competencies 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 Values 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 & 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 4 semanas
Barcelona, España Almirall A tiempo completoCMC Biologics Analytical Senior Scientist The Biologics Development department in Almirall is growing, and we are looking for an Analytical Lead/Scientist to help us bring the best innovative biopharmaceuticals to patients. This position is based in our R&D center in Barcelona.Our biologics pipeline is expanding, and we need your expertise to ensure our end...
-
Cmc Biologics Analytical Senior Scientist
hace 4 semanas
Barcelona, España Almirall A tiempo completoCMC Biologics Analytical Senior ScientistThe Biologics Development department in Almirall is growing, and we are looking for an Analytical Lead/Scientist to help us bring the best innovative biopharmaceuticals to patients. This position is based in our R&D center in Barcelona.Our biologics pipeline is expanding, and we need your expertise to ensure our end...
-
Cmc Biologics Analytical Senior Scientist
hace 1 mes
Barcelona, España Almirall A tiempo completoDate: 15 Oct 2024 Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain Company: Almirall Mission The Biologics Development department in Almirall is growing and we are looking for a Analytical Lead/Scientist that is going to help us bring the best innovative biopharmaceuticals to patients and will join the team in our R&D center in Barcelona!Our...
-
Biologics Development Scientist
hace 1 mes
Barcelona, Barcelona, España Almirall A tiempo completoJob Title: Biologics Development ScientistAbout the Role:Almirall is seeking a Biologics Development Scientist to join our team in Barcelona. As a key member of our Biologics Development group, you will be responsible for leading analytical activities and driving GMP QC activities for antibody-based molecules.Key Responsibilities:• Develop and implement...
-
Biologics Development Scientist
hace 1 mes
Barcelona, Barcelona, España Almirall A tiempo completoBiologics Development ScientistWe are seeking a highly skilled Biologics Development Scientist to join our team at Almirall. As a key member of our Biologics Development group, you will be responsible for leading analytical activities and driving GMP QC activities for antibody-based molecules.Key Responsibilities:Day-to-day oversight of analytical activities...
-
Senior Biologics Development Scientist
hace 3 semanas
Barcelona, Barcelona, España Almirall A tiempo completoBiologics Development Department: We are seeking a highly skilled Analytical Senior Scientist to join our team in Barcelona. As a key member of our Biologics Development group, you will play a critical role in driving the success of our biologics pipeline.Key Responsibilities:Lead all analytics-related topics, including method development and comparability...
-
Cmc Regulatory Affairs Director Biologics
hace 1 mes
Barcelona, España Astrazeneca A tiempo completo.CMC Regulatory Affairs Director BiologicsLocation: Barcelona, Spain (we require 3 days working from the office and 2 days working from home)Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development,...
-
Cmc Regulatory Affairs Director Biologics
hace 1 mes
Barcelona, España Astrazeneca A tiempo completoCMC Regulatory Affairs Director BiologicsLocation: Barcelona, Spain (we require 3 days working from the office and 2 days working from home) Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development,...
-
Cmc Expert
hace 6 meses
Barcelona, España Asphalion A tiempo completo**Main responsibilities**: - CMC project lead/responsible person, reporting to CMC Director. - Overall CMC writing/management of product-specific dossiers (Mod. 2/Mod. 3), including, but not limited to, new registration packages, variation packages and renewal packages in the EU, US and RoW markets. - High-quality strategic support to CMC roadmaps, dossier...
-
Barcelona, España Astrazeneca A tiempo completoCMC Regulatory Affairs Associate Director BiologicsLocation - BarcelonaCompetitive salary and benefits packageIntroduction to roleJoin our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy, Biopharmaceutical and Global Supply...
-
Cmc Regulatory Affairs Associate Director Biologics
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**CMC Regulatory Affairs Associate Director Biologics** **Location - Barcelona** **Competitive salary and benefits package** **Introduction to role** Join our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy,...
-
Cmc Regulatory Affairs Associate Director
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...
-
Regulatory Affairs CMC Specialist
hace 4 semanas
Barcelona, Barcelona, España Galderma A tiempo completoJob Title: Regulatory Affairs CMC SpecialistJob Description:We are seeking an experienced Regulatory Affairs CMC Specialist to join our team at Galderma. As a key member of our regulatory affairs team, you will be responsible for preparing and updating CMC (Chemistry, Manufacturing, and Control) dossier sections for assigned products.Key Responsibilities:•...
-
Scientist For Biologics Quality Control
hace 1 mes
Barcelona, España Kymos Group A tiempo completo.KYMOS 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 Liaison 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...
-
Scientist For Biologics Quality Control
hace 1 mes
Barcelona, 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 Liaison 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...
-
RA-CMC Specialist
hace 7 meses
Barcelona, España Galderma A tiempo completoDescription We are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs). This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities. Key Responsibilities...
-
Scientist in Biological Products
hace 2 semanas
Barcelona, Barcelona, España Kymos Group A tiempo completoKymos Group is a Contract Research Organization (CRO) that offers comprehensive bioanalytical and CMC analytical services to the life sciences industry. We are committed to providing high-quality services to our partners and promoting diversity and inclusion within our organization.We are seeking a qualified Scientist to join our Biologics Quality Control...
-
Ra-Cmc Specialist
hace 1 mes
Barcelona, España Galderma A tiempo completo.With 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...
-
Scientist for Biologics Quality Control
hace 3 días
Barcelona, 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 Liaison 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...
-
Scientist for Biologics Quality Control
hace 3 semanas
Barcelona, 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 Liaison 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...