Scientist - Specialty Team

2 weeks ago

Hyderabad Telangana, India Novartis Argentina Full time

Job ID- 365358BR- Mar 08, 2023- India**Job Description**:

- 1886 We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
- Your key responsibilities:

- Your responsibilities include, but are not limited to:
- Independently design, plan, organize, perform and document scientific experiments/GMP testing/plant activities under mínimal supervision; multitask activities at a time; understand and meet customer needs - own and utilize complex 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, draw relevant conclusions independently and design next experiments; supervise project related scientific/technical activities. Review and verify raw data generated by others
- Write protocols, scientific reports, lab procedures or SOPs; write scientific documents intended for external partners (e.g., other line units, authorities, external companies) or for generation of registration documents under mínimal supervision.
- Communicate, address and solve problems (e.g. deviations and unexpected results from experiments) within own and broader area of responsibility; communicate effectively across organizational interfaces; lead the transfer of know-how or procedures to other departments or external contractors, including troubleshooting and on-site training.
- For technical development units: Develop new methods/processes or optimize existing methods/processes (lab or plant); contribute to development and implementation of new technologies. For GMP units: ensure compliance to cGMP
- For technology-focused role: 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, presentations and patents
- For project-focused role: Lead/coordinate assigned functional sub-teams; participate in function-specific teams and fulfill assigned project tasks and responsibilities under mínimal supervision. Support non-project activities as needed, such as Op Ex, GDP coordinator etc.

**Diversity & Inclusion / EEO**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum Requirements**:

- What you’ll bring to the role:
- PhD in analytical or equivalent field with 2-4 years or PG in analytical or equivalent field with 7-10 years of relevant experience.
- Extractable & Leachable experience
- Must have extensively worked on Extractable & Leachable.
- Experience with in-use studies for drug product delivery systems, simulation studies, and migration studies with respect to secondary packaging’s such as labels, inks, and dyes.
- Glass delamination studies, Depyrogenation of vials studies using different analytical techniques.- Nitrosamine’s experience
- Must have extensively worked on quantification of Nitrosamines including NDSRi’s.
- Must have expertise on qualitative and quantitative analysis using GCMS, LCMS, HRMS techniques
- Excipient testing using IC.
- Knowledge on different Insilico assessment tools
- Mutagenic impurities- 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. Knowledge of current Good Manufacturing Practices (cGMP)
- Presentation skills

Why consider Sandoz?
- 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
- How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughe

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