Senior Chemist 1

327546BR
Oct 01, 2021
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. The role will be responsible to establish and maintain testing of drug substance release and stability testing including testing of intermediates in process control samples in accordance with written testing SOP’s and in accordance with written testing SOP’s and local/international regulations.

Key Responsibilities
• Deliver accurate and timely lab test results and solutions to ensure full cGMP-compliance of IPC/DS (In Process control/ Drug substances) shift team.
• Provides technical support to run and validate necessary test methods on lab equipment and resolve is-sues in day to day lab operations including troubleshooting of lab equipment and processes and liaising with manufacturing teams.
• Leads in developing method transfer/validation protocols, lab equipment qualification and improvement project
• Act as SME (Subject Matter Experts) to train and guide site personnel to perform new methods and in-strumentation, other lab related areas and audit preparation.
• Carry out investigations and establish root cause and prepare report findings according to global and lo-cal standards and requirements.
• Monitoring and optimization of work flows and methods/procedures, drug substance control, method controls and reference’s and performs trending of on-going in process control data to pursue an on-going quality assurance program.
• Reviews all lab related QC documents to ensure completeness, accuracy, consistency, and transparency and that materials or final products have been manufactured, tested, or inspected according to specifica-tion and cGMPs.
• Able to support rotating shift hours (Day/night) i.e. 8am to 8pm and 8pm to 8am

Diversity & Inclusion / EEO

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

Minimum Requirements

• MSc or BS in Pharmacy, Biotechnology, or Chemistry
• 7+ years industry experience, preferably in a cGMP environment. Related experience should be in GMP-regulated industries in Quality Control
• Must have a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems
• Must have an understanding of pharmaceutical industry trends and practices
• Chemical, analytical and biological know-how, Thorough regulatory GMP knowledge, validation and qualification knowledge
• Proficiency in analytical testing methods like HPLC, UV, TOC and other compendia testing
• Ability to work off shifts

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 at Novartis!

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 QUALITY
Singapore
Singapore
Quality
Full Time
Regular
Yes
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327546BR

Senior Chemist 1

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