SENIOR SCIENTIST Drug-Device Combination Products Lead

hace 3 días

Sant Feliu de Llobregat, España Almirall A tiempo completo

SENIOR SCIENTIST Drug-Device Combination Products Lead Lead the development and integration of drug-device combination products for injectable biologics, ensuring technical excellence, regulatory compliance, and patient‑centric design. Key Responsibilities Define and execute strategy for combination product development, focusing on injectable formats (e.g., prefilled syringes, autoinjectors). Manage device component selection, compatibility studies, and integration with biologic formulations. Coordinate with external device manufacturers and internal stakeholders to ensure design control and risk management. Oversee stability studies, usability testing, and regulatory documentation for combination products. Ensure alignment with EU and FDA combination product regulations. Represent Biologics Development in cross‑functional teams including Device Engineering, Regulatory Affairs, and Clinical Supply. Profile Requirements Degree in Biomedical Engineering, Pharmacy, Biotechnology, or related discipline. 5+ years of experience in drug‑device combination product development, preferably injectables. Strong understanding of device regulations, human factors, and design control. Experience with biologics formulation and packaging systems. Fluent in English. Excellent organizational and stakeholder management skills. Why work with Almirall? We are a people‑centric company where employees are at their best, patients and customers are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all. We have been certified Top Employer in Spain for 17 years and also Top Employer Germany for the first time. Our workplace helps employees develop their skills to the fullest, grow professionally and as individuals. We have a proactive, innovative team that transforms the world of people with skin conditions. We are proud of each employee’s development and growth. Our Purpose Transform the patients’ world by helping them realize their hopes & dreams for a healthy life. Our Values Care: We listen & empathize, value diverse perspectives and backgrounds, and help each other succeed. Courage: We challenge the status quo, take full ownership, and learn from our successes and failures. Innovation: We put the patient and customer at the center, create novel solutions, and empower entrepreneurial mindsets. Simplicity: We act decisively, avoid over‑analysis, understand why before we act, and stay agile & keep things simple. At Almirall, it’s all about people #J-18808-Ljbffr

  • SENIOR SCIENTIST Drug-Device Combination Products Lead

    hace 7 días

    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    MissionLead the development and integration of drug-device combination products for injectable biologics, ensuring technical excellence, regulatory compliance, and patient-centric design.Key ResponsibilitiesDefine and execute strategy for combination product development, focusing on injectable formats (e.g., prefilled syringes, autoinjectors).Manage device...

  • SENIOR SCIENTIST Drug-Device Combination Products Lead

    hace 7 días

    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    MissionLead the development and integration of drug-device combination products for injectable biologics, ensuring technical excellence, regulatory compliance, and patient-centric design.Key ResponsibilitiesDefine and execute strategy for combination product development, focusing on injectable formats (e.g., prefilled syringes, autoinjectors).Manage device...

  • SENIOR SCIENTIST Drug-Device Combination Products Lead

    hace 1 semana

    San Feliú de Llobregat, España Almirall A tiempo completo

    Mission Lead the development and integration of drug-device combination products for injectable biologics, ensuring technical excellence, regulatory compliance, and patient-centric design. Key Responsibilities Define and execute strategy for combination product development, focusing on injectable formats (e.g., prefilled syringes, autoinjectors). Manage...

  • Biologics Drug Substance Senior Scientist

    hace 2 semanas

    Sant Feliu de Llobregat, España Almirall A tiempo completo

    Biologics Drug Substance Senior ScientistLa siguiente información ofrece un resumen de las habilidades, cualidades y cualificaciones necesarias para este puesto.Join to apply for the Biologics Drug Substance Senior Scientist role at AlmirallMissionLead the development and oversight of Drug Substance (DS) activities, with a strong focus on Downstream...

  • Corporate Senior Medical Device Quality Assurance Specialist

    hace 5 días

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    WE ARE HIRING!CORPORATE SENIOR QUALITY SPECIALIST- Medical Device Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.Being part of this team does not mean you are just working for a company, but for a cause!Neuraxpharm...

  • Cmc Biologics Analytical Senior Scientist

    hace 19 horas

    Sant Feliu de Llobregat, España Almirall A tiempo completo

    **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...

  • Analysis Senior Scientist

    hace 5 días

    Cornellà de Llobregat, España Johnson & Johnson Innovative Medicine A tiempo completo

    Senior Scientist – Generative AI for Content Authoring Join to apply for the Senior Scientist – Generative AI for Content Authoring role at Johnson & Johnson Innovative Medicine Join to apply for the Senior Scientist – Generative AI for Content Authoring role at Johnson & Johnson Innovative Medicine At Johnson & Johnson, we believe health is...

  • Senior Scientist, non-clinical

    hace 2 semanas

    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    MissionDefine and drive non-clinical and clinical PK/PD strategies for NCE, NBE or other drug modalities, through modeling & simulation tools to support hypothesis generation, candidate selection, human dose predictions, design of clinical trials or regulatory interactions. Provide guidance with respect to common model informed drug development (MIDD) needs,...

  • Senior Scientist, non-clinical

    hace 7 días

    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    MissionDefine and drive non-clinical and clinical PK/PD strategies for NCE, NBE or other drug modalities, through modeling & simulation tools to support hypothesis generation, candidate selection, human dose predictions, design of clinical trials or regulatory interactions. Provide guidance with respect to common model informed drug development (MIDD) needs,...

  • computer-aided drug design trainee

    hace 2 semanas

    Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completo

    OverviewAlmirall is seeking a young scientist to work as an intern for the Computer-Aided Drug Design section of the R+D Data Science Dpt. with the mission of contributing to the design of NCEs to accelerate a series of discovery programsJob ResponsibilitiesParticipate in a variety of in silico tasks related to Almirall's drug discovery projectsLearn and...