Empleos actuales relacionados con Cmc Biologics Analytical Senior Scientist - Sant Feliu de Llobregat, Barcelona - Almirall
-
Biologics Drug Product Senior Scientist
hace 2 semanas
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoAbout the RoleWe are seeking a highly skilled Biologics Drug Product Senior Scientist to join our team at Almirall. As a key member of our R&D centre in Barcelona, you will play a crucial role in the development of our biologics pipeline.Your primary focus will be on expanding our competences within Primary Packaging, Sterile Fill-Finish processes, Drug...
-
Biologics Drug Product Senior Scientist
hace 2 semanas
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoAbout the RoleWe are seeking a highly skilled Biologics Drug Product Senior Scientist to join our team at Almirall. As a key member of our R&D centre in Barcelona, you will play a crucial role in the development of our biologics pipeline.Your primary focus will be on expanding our competences within Primary Packaging, Sterile Fill-Finish processes, Drug...
-
Data Scientist Senior
hace 6 días
Hospitalet de Llobregat, Barcelona, España GMV A tiempo completo{"h1": "Data Scientist Senior at GMV", "p": "At GMV, we are seeking a highly skilled Data Scientist Senior to join our team. As a key member of our data science team, you will be responsible for developing and implementing predictive solutions and improving operations and services through data interpretation and application in a public transport context.",...
-
Corporate Pharmacovigilance Senior Scientist
hace 1 semana
Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completoJob Title: Corporate Pharmacovigilance Senior ScientistWe are seeking a highly skilled and experienced Pharmacovigilance Senior Scientist to join our Corporate team at Neuraxpharm. As a key member of our team, you will play a crucial role in ensuring the safety and efficacy of our medicinal products.About the Role:The successful candidate will be responsible...
-
Corporate Pharmacovigilance Senior Scientist
hace 1 semana
Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completoJob Title: Corporate Pharmacovigilance Senior ScientistWe are seeking a highly skilled and experienced Pharmacovigilance Senior Scientist to join our Corporate team at Neuraxpharm. As a key member of our team, you will play a crucial role in ensuring the safety and efficacy of our medicinal products.About the Role:The successful candidate will be responsible...
-
Corporate Pharmacovigilance Senior Scientist
hace 3 días
Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completoJob Title: Corporate Pharmacovigilance Senior ScientistWe are seeking a highly skilled and experienced Corporate Pharmacovigilance Senior Scientist to join our team at Neuraxpharm. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety of our medicinal products and compliance with regulatory...
-
Corporate Pharmacovigilance Senior Scientist
hace 3 días
Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completoJob Title: Corporate Pharmacovigilance Senior ScientistWe are seeking a highly skilled and experienced Corporate Pharmacovigilance Senior Scientist to join our team at Neuraxpharm. As a key member of our Pharmacovigilance department, you will play a critical role in ensuring the safety of our medicinal products and compliance with regulatory...
-
Senior Data Scientist
hace 2 semanas
Hospitalet de Llobregat, Barcelona, España GMV A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Data Scientist to join our team at GMV. As a key member of our data science team, you will play a critical role in the development and implementation of predictive solutions and the continued improvement of operations and services.Key ResponsibilitiesDesign, construction, and maintenance of data...
-
Senior Data Scientist
hace 2 semanas
Hospitalet de Llobregat, Barcelona, España GMV A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Data Scientist to join our team at GMV. As a key member of our data science team, you will play a critical role in the development and implementation of predictive solutions and the continued improvement of operations and services.Key ResponsibilitiesDesign, construction, and maintenance of data...
-
Data Scientist Senior
hace 3 días
Hospitalet de Llobregat, Barcelona, España GMV A tiempo completoJob DescriptionAt GMV, we are seeking a highly skilled Data Scientist Senior to join our team. As a key member of our data science team, you will play a crucial role in the development of predictive solutions and the improvement of operations and services.Key ResponsibilitiesDesign, build, and maintain data infrastructure and databases.Develop and optimize...
-
Data Scientist Senior
hace 3 días
Hospitalet de Llobregat, Barcelona, España GMV A tiempo completoJob DescriptionAt GMV, we are seeking a highly skilled Data Scientist Senior to join our team. As a key member of our data science team, you will play a crucial role in the development of predictive solutions and the improvement of operations and services.Key ResponsibilitiesDesign, build, and maintain data infrastructure and databases.Develop and optimize...
-
Associate Director, IT Delivery Area
hace 2 semanas
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoJob SummaryWe are seeking an experienced Associate Director to lead and execute strategic IT programs that improve the capabilities and performance of R&D at Almirall. The successful candidate will have a strong background in IT project management, process design, and system validation practices, with direct exposure to business.Key ResponsibilitiesLead IT...
-
Associate Director, IT Delivery Area
hace 2 semanas
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoJob SummaryWe are seeking an experienced Associate Director to lead and execute strategic IT programs that improve the capabilities and performance of R&D at Almirall. The successful candidate will have a strong background in IT project management, process design, and system validation practices, with direct exposure to business.Key ResponsibilitiesLead IT...
-
Senior Data Scientist
hace 2 semanas
Cornellà de Llobregat, Barcelona, España Importante empresa A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Data Scientist to join our Global Business team in Barcelona. As a key member of our interdisciplinary team, you will be responsible for building deployable statistical and machine learning models, starting from the discovery phase.Key ResponsibilitiesCollaborate with data engineers to ensure data access...
-
Senior Data Scientist
hace 2 semanas
Cornellà de Llobregat, Barcelona, España Importante empresa A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Data Scientist to join our Global Business team in Barcelona. As a key member of our team, you will be responsible for building deployable statistical and machine learning models to support our global digital developments.Key ResponsibilitiesPartner with data engineers to ensure data access and preparation...
-
Senior Data Scientist
hace 2 semanas
Cornellà de Llobregat, Barcelona, España Importante empresa A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Data Scientist to join our Global Business team in Barcelona. As a key member of our team, you will be responsible for building deployable statistical and machine learning models to support our global digital developments.Key ResponsibilitiesPartner with data engineers to ensure data access and preparation...
-
Senior Data Scientist
hace 2 semanas
Cornellà de Llobregat, Barcelona, España Importante empresa A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Data Scientist to join our Global Business team in Barcelona. As a key member of our interdisciplinary team, you will be responsible for building deployable statistical and machine learning models, starting from the discovery phase.Key ResponsibilitiesCollaborate with data engineers to ensure data access...
-
Senior Data Scientist
hace 2 semanas
El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Data Scientist to join our Life Sciences and Healthcare team at Clarivate. As a key member of our team, you will be responsible for developing and implementing cutting-edge machine learning and AI models to support our business goals.Key ResponsibilitiesResearch and identify machine learning and natural...
-
Senior Data Scientist
hace 2 semanas
El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoAbout the RoleWe are seeking a highly skilled Senior Data Scientist to join our Life Sciences and Healthcare team at Clarivate. As a key member of our team, you will be responsible for developing and implementing cutting-edge machine learning and AI models to support our business goals.Key ResponsibilitiesResearch and identify machine learning and natural...
-
Corporate Pharmacovigilance Senior Scientist
hace 1 semana
Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completoAbout the RoleWe are seeking a highly skilled Pharmacovigilance Senior Scientist to join our team at Neuraxpharm. As a key member of our Corporate PV department, you will play a crucial role in ensuring the safety of our medicinal products and complying with regulatory requirements.Key ResponsibilitiesSupport the management of safety profiles for all...
Cmc Biologics Analytical Senior Scientist
hace 3 meses
Date:28-Apr-2023
Location:
SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain
Company:
Almirall
/ MISSION:
The Almirall R&D team in Barcelona is building up the Biologics Development department and is looking for a talented and experienced CMC Biologics Analytical Senior Scientist.
The Biologics Development department is responsible for the preclinical and clinical stages of CMC development of all New Biologics Entities (NBEs) developed by Almirall up to commercial registration.
CORE RESPONSIBILITIES:
- Daytoday 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 inhouse 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.
REQUIRED 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 with NBEs is preferred.
PREFERRED SKILLS & COMPETENCES:
- 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
