SENIOR SCIENTIST Drug-Device Combination Products Lead
hace 5 días
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 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 customer are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all. Additionally, for the 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time. This strengthens our commitment to create a unique work environment that helps our employees to develop their skills to fullest and grow both professionally and as individuals. We are delighted to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions. We are proud of each one of our employees , their development, and growth: they are the success of the company. Our purpose "Transform the patients' world by helping them realize their hopes & dreams for a healthy life". Our 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. At Almirall, it's all about people #wearealmirall #J-18808-Ljbffr
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