Jul 19, 2022

Job Description

Process Expert, Novartis, Basel, Switzerland

Over 799 million! - that's how many lives we reached with our products in 2021. And while we are proud of this, we continuously ask ourselves the question: how can we improve and extend even more lives in a world of digital and technological change? We are convinced that we can find answers if curious, courageous and team-oriented people are encouraged to question the status quo, make courageous decisions and follow innovative paths. Our Biotechnology Drug Substance Technology Platform includes 6 Drug Substance sites supplying new biologics entities and biosimilars.
Process Expert provides front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, Standard Operations Procedures and applicable guidelines and functional standards and to allow continuously improving in quality, productivity and efficiency.

This role is currently limited until end of 2024.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Act as Subject Matter Expert for the product and process.
• Ensure the management of all validation, revalidation, qualification, respecting deadlines and current regulations and execute validations when/where needed.
• Develop technical and scientific knowledge of Experts and shop floor technicians.
• Lead thorough Root Cause Investigation process for major and critical deviations using investigation tools and methodology.
• Perform production impact assessment for complex changes change controls (product and asset change controls).
• Prepare, support and follow-up of Health authority and internal inspections.
• Collaborate with Regulatory Compliance QA for dossier submissions, revisions.
• Ensure implementation and maintenance of the quality systems with the site in accordance with corporate and regulatory guidelines. Support & Perform Optimization projects using Six Sigma Methodology and collaborate with MS&T & technical Development teams for transfer & launch for assigned products, ensure product is fit for plant, support scale up & process improvements.

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:

• University degree in Science is desirable, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent
• Biotechnology experience in DSP/USP desirable
• Minimum 2 years of experience in GMP manufacturing process support
• Good understanding of regulatory requirements across multiple health authorities
• Good working knowledge/understanding of manufacturing execution systems ( SAP, or relevant...)
• Fluent German and English language knowledge (spoken and written)
• Team player with strong team spirit; open for feedback to learn and grow in the role
• Good communication skills and potential to adapt to diverse learning styles

Why consider Novartis?

769 million lives were touched by Novartis medicines in 2020, 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!

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.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

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
Technical Operations
Full Time
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Process Expert

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