339738BR
Mar 10, 2022
Switzerland

Job Description

200+! The number of programs in clinical development at Novartis.

Behind each of these program is a drug that is 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 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:
As a senior analytical project leader, your responsibilities include but are not limited to :
• Co-owning the technical drug development of innovative new drugs, essentially small molecules intended for oral use
• Establishing and driving the overall analytical project strategy throughout late phase clinical development activities and as basis for routine commercial operations for both APIs and formulated drug products
• Leading and managing all analytical activities within a global project team (e. g. specification setting, method development and validation, stability and release testing, transfer to commercial organization)
• Accountability to meet quality, timelines and budget for assigned projects, defining and presenting analytical project plans and contributing to the overall CMC project development plan.
• Leading interactions with internal and external stakeholders, 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
• Strong contribution to advance science, technology and innovation within Analytical Research & Development as well as to shape the future of pharmaceutical development. Developing, mentoring and coaching peers and scientific associates helping them grow their potential.

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:
• Minimum BS / MS in analytical chemistry, organic chemistry or pharmaceutical development with significant experience in industry
• Minimum 10 years’ experience in the pharmaceutical industry / drug development, preferably in analytical R&D or quality control
• Proven leadership experience in managing projects ideally in a global matrix environment
• Strong quality focus, proficiency in quality principles driving drug development such as GMP and QbD environment, deep understanding of current and anticipated regulatory expectations, profound scientific knowledge in analytical chemistry
• Proficient 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
careers default image
339738BR

Senior Analytical Project Leader (80-100%)

Apply to Job Access Job Account