345949BR
Jun 13, 2022
Switzerland

Job Description

300 Million. This is the number of people suffering from autoimmune diseases worldwide. Join our team in our most advanced biopharmaceutical production and help to improve their lives.

The AS&T Specialist is active in the area of analytics, supporting the laboratory team with in-depth knowledge to ensure efficient performance of laboratory activities and related investigations in compliance with GxP and HSE guidelines. Our colleague will also perform reviews and approvals of analytical data as well as be responsible for analytical launch and transfer activities.


MAJOR ACCOUNTABILITIES:

Operational
• Responsible for managing the stability program for Stein Large molecules (protocols, reports, data evaluation, investigation, sample management)
• Leads analytical transfers out (CMO, CPO, external labs...)
• SME for medical device testing and implementation
• Product and process validation support as well as qualification analytics
• Ensure all activities are in compliance with cGxP, incl. data integrity
• Liaison with partners across the business
• Potential product responsibility across multiple sites

HSE
• Follow all HSE guidelines
• Detect and report potential accident, risks and propose solutions
• Participate in HSE risk assessments and prepare internal HSE audits
• Responsible for participating in initial training and retraining


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

• Expertise in highly specialized analytical technique(s) eg. CE-SDS, HPLC
• Prior experience with medical device (Syringes, auto-injector, needle safety device) is a plus
• Sound technical understanding; experience in pharmaceutical or chemical analytics/QC or equivalent
• Technical education & 3-5 years relevant experience or University degree in Pharmacy, Chemistry or equivalent (desirable) + 3-4 years working experiences
• Good oral and written English skills; proficient in German (oral and written) is a plus
• Exceptional communication skills and ability to work independently in a matrix environment
• MS Office applications and other standard IT applications supporting Quality activities
• Familiar with Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes
• Laboratory Excellence; Quality decision making; Good communication skills.

You’ll receive:

We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Novartis also supports a flexible work-life integration (working remotely, flexi-time schedules, ...).

Why consider Novartis?

769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!
Novartis Technical Operations
NTO QUALITY
Switzerland
Stein (Säckingen)
Quality
Full Time
Regular
No
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345949BR

AS&T Specialist

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