We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, Shigella and Zika.
Responsibilities
As a Principal Scientist (m/f/d), you will play a pivotal role in driving analytical life cycle management for our commercial products, being located at the Vienna site. You will provide scientific and technical expertise, ensure regulatory compliance, and lead strategic projects from conception to validation. Your key responsibilities will be::
Manage life cycle management (LCM) activities of analytical testing for all Valneva’s commercial products
Identify and prepare LCM proposals, including cost, resources, and milestones
Lead or support LCM projects from conception to validation and CMC documentation compilation
Provide technical and scientific expertise to both LCM and development projects
Drive continuous method improvements and support key business deliverables
Represent the company in technical discussions with customers, suppliers, and regulatory authorities
Act as Product Owner for at least one commercial product
Serve as second-line support in technical investigations, using statistical data analysis and trending
Maintain alignment with the global Technical Development and Quality organization
Ensure training standards are met; contribute to a collaborative and supportive team environment
Deputize for line manager or colleagues when required
PhD in biologics/biopharma with relevant industrial experience
Industry and analytical background, ideally with experience in quality control and/or vaccine-related environments
Proven experience in managing CMC-related regulatory variations
Strong knowledge of GMP regulations and regulatory processes
Experience in interacting with regulatory authorities
Experience in statistical data analysis, change management, lean systems, and risk analysis
Excellent communication and report writing skills
Ability to lead complex projects and deliver under tight timelines with changing priorities
Strong problem-solving and analytical thinking abilities
Team-oriented mindset with awareness of impacts on people, processes, and systems
Working with Valneva means being part of a global biotech company with a clear vision to make a meaningful impact in the world. At Valneva, you can expect a dynamic and innovative work environment characterized by an open, appreciative company culture and exciting, impactful assignments. Enjoy the benefits of flat hierarchies, an international atmosphere, and regular company events that foster collaboration and connection.
Lifelong learning: Unlimited access to LinkedIn Learning & German/English courses for free
Health & Wellbeing: Free access to sports and fitness activities via myClubs & Office Massages
Join us and shape the future of biotechnology! Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 85.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.
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