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Job Details


Novartis

Sr Process Scientist (341233BR)

Pharmaceuticals

All

Yearly

No

Indianapolis, Indiana, United States

Job Description 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. 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 toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

The Sr Process Scientist owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability through data trending and statistical analysis of critical variables, and ensures process(es) are robust, in continued state of validation and continuously improving. Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support. Manages and collaborates with external consultants to achieve document generation and execution according regulatory and project requirements.

Your responsibilities include, but are not limited to:

• Maintain the oversight and knowledge for entire manufacturing process performed on site throughout the entire commercial lifecycle, act as SPOC.
• Ensure an appropriate process control strategy is in place based on CQAs and where necessary on CPPs and/or CMAs. Support improving the control strategy where applicable.
• Create Process Validation protocols and generate reports (as needed) and responsible for ensuring the continued state of validation (process, cleaning, etc.).
• Monitor all critical variables, key variables, In Process Controls (IPC) and release parameters as appropriate using statistical analysis and conducting regular product specific data trending.
• Lead/support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
• Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.
• Provide SME expertise to perform process characterization to increase robustness and sustainability.

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