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The GMP Quality Auditor is responsible for planning and conducting audits in accordance with GxP regulations, maintaining audit documentation, collaborating with stakeholders, and ensuring compliance with quality standards. They will supervise trends in regulatory agency findings and prepare comprehensive audit reports while providing mentorship for corrective actions.
The Senior Manager Market Access oversees HTA submissions, pricing implementation, negotiation, and tender strategy in the Benelux and Nordic Markets. They coordinate cross-functional strategies with global and affiliate teams, develop pricing strategies with the Affiliate Commercial team, support market access plans, and assess new product launches.
The Sr. Bioinformatics Data Analyst will lead and contribute to the software lifecycle of Scientific Data Applications, collaborating with scientists to enhance data models and accessibility. Responsibilities include designing scalable data solutions, analyzing data issues, unifying master data for quality improvement, and mentoring team members on best practices in data solutions and architecture.
The Principal Statistical Programmer will lead and support programming activities for clinical studies, ensuring high-quality programming deliverables. Responsibilities include programming support, documentation development, and assisting regulatory submissions. The role requires analytical proficiency and collaboration with internal teams.
The Sr. Application Developer will develop and maintain applications for analyzing genetic data, modernize existing applications, implement user-requested features, and provide support to users. The role requires collaboration with a diverse team and a strong interest in computational genomics.
The Process Development Engineer II will develop scalable downstream processes for early-stage medicine, perform experiments, document results, address instrumentation problems, develop new technologies for manufacturing, and collaborate with various teams. A strong ability to learn, work independently or in teams, and communicate effectively is required.
The Scientist will support the development of cell and gene therapies, focusing on mammalian cell culture, T cell preparation, retroviral vector design, and various assays and molecular biology techniques. You will work independently and collaboratively in a fast-paced environment, utilizing skills in flow cytometry and cell manipulation, among others, to drive innovation in bispecifics.
The Staff CMC Regulatory Sciences Specialist oversees CMC aspects of global submissions, focusing on regulatory strategies and the preparation of submissions for non-US/EU markets. The role involves developing processes, managing cross-functional teams, providing regulatory guidance, and monitoring trends in non-US/EU markets.
The Process Development Associate II in Purification Development is responsible for developing purification processes, documenting experiments, maintaining laboratory instruments, and supporting technology transfers. You will also engage with team members to improve efficiency and safety, present findings in meetings, and assist in training peers and interns.
As a Process Development Associate II in Analytics, you will perform analytical experiments to support biopharmaceutical manufacturing process development. Your role involves high throughput analysis, statistical evaluations of assay performance, communication with project teams, and developing new analytical assays within a collaborative environment.
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