328977BR
Nov 05, 2021
Switzerland

Job Description

90! The number of New Molecular Entities currently in clinics awaiting to be transformed into successful high quality innovative medicines and in need of Analytical Project Leaders in charge of the development of analytical control strategies throughout development, from the time they leave the discovery laboratory until the transfer to commercial production.

As part of the Analytical Research and Development (ARD) group, this is a new role waiting for you to put your own stamp on it. The position is located at the Novartis Headquarter site in Basel within the Technical R&D (TRD) department of Global Drug Development.

Your responsibilities include but are not limited to :
• Developing and driving the overall analytical project strategy (API and formulated drug product, essentially small molecules intended for oral use)
• Leading and managing all analytical activities within a global project team (e. g. specification setting; method development, validation and transfer; stability and release testing)
• Accountability to meet quality, timelines and budget for assigned projects, defining analytical project plans
• Leading interactions with internal and external stakeholders (Chemical/Pharmaceutical development, Technical Operations, Global Clinical Supplies, Quality Assurance, Regulatory...), including potential outsourced activities
• Proactively identifying potential scientific, technological and GMP gaps, proposing creative solutions and ensuring appropriate communication within and across units
• Providing input into CMC documents to support regulatory submissions for clinical trial applications as well as registration
• Strong contribution to advance science, technology and innovation within ARD

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

What you’ll bring to the role:
• Minimum BS / MS in analytical chemistry with significant experience in industry; PhD in analytical chemistry or equivalent desirable
• Minimum 5 years’ experience in the pharmaceutical industry, preferably in analytical development or quality control
• Proven leadership experience in leading projects ideally in a global matrix environment
• Strong quality focus, experience in a GMP environment
• Understanding of regulatory expectations and profound scientific knowledge in analytical development of drug substances and/or drug products
• Fluent in English (oral and in writing)
• Ability to perform in a highly dynamic environment

Why 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!
Global Drug Development
TECHNICAL R & D GDD
Switzerland
Basel
Research & Development
Full Time
Regular
No
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328977BR

Analytical Project Leader (80-100%)

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