Biologics Drug Substance Senior Scientist
hace 2 días
Biologics Drug Substance Senior ScientistJoin to apply for the Biologics Drug Substance Senior Scientist role at Almirall MissionLead the development and oversight of Drug Substance (DS) activities, with a strong focus on Downstream Processing (DSP) and strategic CMC leadership across biologics programs. Ensure alignment with regulatory standards and internal quality systems throughout the product lifecycle. Key ResponsibilitiesProvide technical leadership in DSP strategy, development and optimization for biologics. Oversee external partnerships for DS manufacturing, ensuring compliance with GLP/GMP and Regulatory requirements. Lead CMC strategy and execution from early development through to regulatory filing. Review and approve technical documentation, deviations, and change controls. Drive cross-functional collaboration with Clinical Operations, Regulatory Affairs, and Quality Assurance. Support regulatory submissions with robust CMC documentation and risk assessments. Mentor junior scientists and contribute to talent development within the Biologics Development team. Profile RequirementsAdvanced degree in Biotechnology, Biochemistry, Pharmacy, or related field. Minimum 5 years of experience in biologics DS development, with proven DSP expertise. Demonstrated CMC leadership across multiple phases of development. Fluent in English. Strong project management and communication skills. A team player with a positive attitude and the ability to work effectively in matrix teams in a fast‑paced environment with changing priorities and a high urgency. Good communication and stakeholder management skills when representing the team in cross‑functional and cross‑site teams and with CDMOs. Empowered, with the ability to plan and proactively handle multiple tasks simultaneously. Experienced with working in an international setting with different cultures and the ability to travel. Why work with AlmirallWe are apeople‑centric companywhere 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 aunique work environment that helps our employees to develop their skills to fullestand 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 areproud 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 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. #wearealmirall#J-18808-Ljbffr
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