341289BR
Jun 14, 2022
Singapore

Job Description

More than 380! That’s the number of associates in our Singapore Large Molecules division to support the making of medicines for our patients worldwide.

As the Senior Product Steward, you will own the process knowledge of the products assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring processes are robust, in continued state of validation and continuously improving.

Key Responsibilities

• 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.
• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
• Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
• Ensure an appropriate process control strategy based on CQA and where necessary on CPP, CMA is in place, support improving the control strategy where applicable.
• Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters.
• 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.
• Design and manage optimization projects as well as providing SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.
• Represent site in product stewardship network

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:

• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
• Minimum 8 year experience in process support, e.g. Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC, with solid biologics experience.
• Proven process understanding (Pharma, GMP, Regulatory aspects and product submission experience).
• Strong project management experience, ability to manage and collaborate with stakeholders well, self-driven

Why consider Novartis?
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 at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO Contract Manufacturing
Singapore
Singapore
Technical Operations
Full Time
Regular
No
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341289BR

Senior Product Steward

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