Beschreibung

In this role, you will engage in diverse activities, including coordinating analytical efforts in customer projects and advising on strategic decisions for biopharmaceutical development, while ensuring quality and compliance throughout.

Anforderungen

• •Degree in Life Sciences (pharmacy, immunology, chemistry, biochemistry) preferably with PhD or several years of industrial experience in biopharmaceutical fields
• •Profound knowledge regarding the assessment of product quality and cQAs in biopharmaceutical products
• •Sound knowledge on chromatographic and/or electrophoretic analytical methods and/or immunoassays
• •Very good knowledge in immunology and/or medical/pharmaceutical knowledge with experience in pharmacokinetics/-dynamics of biopharmaceuticals
• •Several years of experience in QbD-based biopharmaceutical development
• •Proficiency in MS-Office programs and fluency in English
• •Collaborative communication skills and confident presentation in front of multidisciplinary teams and external customers
• •Scientific curiosity, analytical thinking, and efficient work in dynamic multifaceted tasks
• •Team player with high initiative and organizational skills

Aufgaben

• •Represent Analytical Science in customer project teams
• •Coordinate Analytical Science activities for assigned customer projects
• •Manage external biophysical analytical activities
• •Contribute to Critical Quality Attributes evaluations
• •Coordinate product characterization studies
• •Implement the Quality-by-Design strategy in project teams
• •Advise teams and clients on cQAs and QbD development
• •Ensure adherence to project timelines and milestones
• •Contribute to product quality risk assessments
• •Prepare and write reports and presentations in English
• •Present results and strategic topics in meetings and conferences

Tools & Technologien

Benefits