Senior Research Scientist NOVRJP00012222

Responsibilities:

• Independently design, plan, organize and perform scientific experiments for the preparation and timely delivery of biologic drug products (DP), processes and procedures.
• Independently design, plan, organize and perform specific analytical tests related to the experiments as well as for related stability studies.
• Documentation of raw data from the scientific experiments including all conducted analytical tests as well as evaluation. interpretation and reporting of all results of the scientific experiments together with the project responsible (Functional Lead).
• Interprets results including drawing relevant conclusions and delivers respective work packages to meet agreed objectives & timelines in the project team. Ensures and drives information exchange in DP sub-team.
• You will be a core member of the Drug Product development sub-team, representing the scientific and technical excellence and you might be a member of the CMC team ad-hoc if required.
• Based on the project status, participate in function-specific project sub team meetings and discussions
• If required, support the compilation of scientific protocols / reports and lab procedures based on existing templates as well as contribute to compilation of SOPs
• Take over responsibility for specific tools / equipment and utilize special tools / equipment or specialized facilities as an expert. Schedule and perform maintenance and qualification of tools / instruments / equipment as needed.
• Develop new methods or optimize existing laboratory methods/processes as well as contribute to development and implementation of new technologies.
• Where applicable take on roles and responsibilities related to operational excellence and/or innovation.
• Work according to appropriate laboratory standards for quality, ethics, health, safety, environment protection, and information security. Support and participate in initiatives to ensure continuous improvement.
• Use professional concepts, company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways. Proactively identify conflict situations and contribute to solutions.
• Actively foster knowledge exchange and contribute to the team objectives

Requirements:

• PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Technology, or equivalent.
• 1-3 years of successful experience in biotech / pharma industry with emphasis on biologics drug product formulation and process development, manufacturing, scale-up, and technology transfer
• Experience in protein analytics, lyophilization, primary packaging development for biologics.
• Experiences in BLA / MAA submission is an advantage
• Hands-on experience in drug product formulation development and analytics for biologics including control for each unit operation, including mixing, filtration, and fill finish, experiences in lyophilization and primary packaging development for biologics is an advantage.
• Proficient in English – spoken and written. Basic or proficient knowledge in German as local language is an advantage.
• Strong skill in MS Office tools (Word, Excel, PowerPoint, TEAMS) as well as Data & Digital savviness
• Highly structured and organized working style. Proven track record for working independently in development laboratory environment including basic knowledge on GLP and HSE requirements for development laboratories. Good understanding of data integrity requirements in development environment.