Scientist, ICP-MS, ICP-OES, AAS, XRF,ICHQ3D , Good Manufacturing Practices,cGMP,Analytical
Your responsibilities include, but are not limited to:
- Independently plan, organize, perform and document scientific experiments/GMP testing/plant activities under minimal supervision; handle several activities at a time
- Take over responsibility for and utilize special tools/equipment or specialized facilities as an expert; schedule and perform maintenance and qualification of instruments/equipment.
- Proactively identify conflict situations and contribute with empathy to solutions
- Work according to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines; lead initiatives to ensure proactive compliance and continuous improvement.
- Provide documentation of raw data, evaluate and interpret results; propose and provide input for the design of next experiments. Review and verify raw data generated by others; approval of test/experiments performed by others.
- Write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision.
- Recognize, communicate, address and solve problems (e.g. deviations and unexpected results from experiments) within own and broader area of responsibility; actively transfer know-how or procedures to other departments or external contractors, including troubleshooting and on-site training. Minimum requirements
WHAT YOU’LL BRING TO THE ROLE:
- Master of Science with atleast 5 year of relevant experience. Fluent in English (oral and written) Basic skills in local site-language, as required for the position .
- Hands on experience on Elemental impurities method development, validation and technology transfer by using different instrument techniques like ICP-MS, ICP-OES, AAS, XRF etc.
- Interpretation of ICHQ3D requirements & knowledge on various regulatory bodies requirements on elemental impurities.
- Deformulation experience in quantifying excipients by using various analytical techniques.
- Process identification through deformulation with various analytical tools.
- Experience on other characterization techniques like LC-MS, GCMS, NMR, FTIR etc... will be an added advantage.
- Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
- Good theoretical and scientific knowledge in the relevant area (e.g. manufacturing, analytical, pharmaceutical).Proficient with laboratory and/or technical tools.Good knowledge of software and computer tools.
- Good documentation skills and Knowledge of current Good Manufacturing Practices (cGMP)
- Presentation skills and Advanced scientific/technical writing skills
- For technical development units: Develop new methods or optimize existing methods (lab or plant);contribute to development and implementation of new technologies.
- For GMP units: ensure compliance to cGMP.
- For technology-focused role: Perform information and literature searches under minimal guidance. Actively foster knowledge exchange. Train and coach associate scientists, technicians, temporary employees and employees under training/education.
- For project-focused role: Participate in function-specific sub teams and fulfill assigned project tasks and responsibilities under supervision. Support non-project activities as needed, such as Op Ex, GDP coordinator etc.