Scientist Biologics Development – Global Drug Development NOVRJP00012223

Responsibilities:

• Design, plan, organize and perform scientific experiments for the preparation and timely delivery of biologic drug products (DP), processes and procedures with minimum supervision
• Design, plan, organize and perform specific analytical tests related to the experiments as well as for related stability studies independently of with minimum supervision
• 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).
• Input to the planning and actively support the design of next experiments based on the results and observations.
• Organize, prepare and coordinate shipments of materials (e.g. samples, materials, tools) related
• Based on the project need, participate in function-specific project sub team meetings and discussions
• In your role as Lab Scientist, you will further support the Drug Product Science Team with the following responsibilities,
• Review and verify raw data generated by other colleagues including approval of tests / experiments performed by others.
• 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:

• Qualification as Laborant / Lab Scientist / Lab technician with focus on Pharmaceutical Technology, alternatively Master of Science (MSc) in life sciences or pharmaceutical technology or equivalent.
• Ideally 1-3 years of successful experience as lab scientist in biotech / pharma industry with emphasis on biologics drug product formulation and process development.
• 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.
• Ideally strong knowledge and hands-on experiences in development of formulations and processes for special protein deliveries as well as for high concentrated protein formulations.
• Strong skill in MS Office tools (Word, Excel, PowerPoint, TEAMS) as well as Data & Digital savviness including basic experiences with digital lab tools for experiment documentation and/or data evaluation and interpretation.
• Basic understanding of statistical data analysis and skills in data presentation is an advantage.
• 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.