Senior Scientist (Clinical Bio-analytics Operations)

Senior Scientist (Clinical Bio-analytics Operations)

Sandoz

Holzkirchen, Germany

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Support set-up of LC-MS/MS technology and capability build for quantitative analysis of complex bio-therapeutics as subject matter experts and specialist in the laboratory and contribute to the required documentation
• Contribute to development and validation of LC-MS/MS methods according to applicable guidelines (i.e. ICH M10), conduct the required experiments
• Independently design, plan, organize, perform and document scientific experiments/ activities in the context of global clinical trials under minimal supervision; multitask activities at a time; understand regulatory requirements
• Own and utilize complex tools/equipment or specialized facilities as an expert; schedule and perform maintenance and qualification of instruments/equipment
• Actively maintain laboratory inventory (e.g. chemicals, standards, consumables) within own area of responsibility
• Work according to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines; lead initiatives/projects to proactively ensure compliance and continuous improvement
• Provide documentation of raw data, evaluate and interpret results, draw relevant conclusions independently and design next experiments; coordinate project-related scientific/technical activities. Review and verify raw data generated by others, check test/experiments performed by others
• Write documents, e.g. scientific plans and reports or lab procedures based on templates or SOPs under minimal supervision
• Provide scientific and technical guidance; perform information and literature searches; actively foster knowledge exchange. Train and coach team members, temporary employees or employees under training; present scientific/technical results internally and contribute to publications and presentations
• Lead/coordinate assigned functional sub-teams; participate in function-specific teams and fulfill assigned project tasks and responsibilities under minimal supervision
• Collaborate within own and with other groups. Proactively identify conflict situations and contribute with empathy to solutions

What you’ll bring to the role:

Essential Requirements:

• Science degree with PhD or Master of Science with 3 years of relevant experience or Bachelor of Science or equivalent technical education with 6 years relevant experience in industry or equivalent
• Basic skills in local site-language, as required for the position
• Experience in GxP LC-MS/MS technology, hands-on experience in setting up and maintaining respective instrumentation preferred
• Awareness for safe handling of chemicals, potentially dangerous materials and equipment
• Broad theoretical and scientific knowledge in the analytical chemistry, immunology, biotechnology and/or related fields Proficient with laboratory and/or technical tools.
• Good knowledge of software and computer tools
• Good documentation skills
• Presentation skills
• Fluent in English (oral and written)
• Advanced scientific/technical writing skills

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Germany      Biotechnology and Genetics      On-site      Pre-clinical Research and Development      Sandoz