Analytical Expert/Analytical Project Leader (80-100%*)
- Basel, Switzerland
50! The number of parenteral, topical, ophthalmic and inhaled projects of our compelling and rich development pipeline. We are searching for an Analytical Expert / Analytical Project Leader to support Analytical Research & Development (ARD).
ARD sits within the Global Technical R&D department of Global Drug Development and plays an essential role in the characterization and analysis of Small Molecule Drug Substances and Drug Products from the time they leave the discovery laboratory until they are transferred to Commercial Production.
We are looking for a highly motivated, experienced Analytical Expert / Analytical Project Leader with a strong background and experience in parenteral and late phase development to join our team. Expertise in oligonucleotide analytics is an asset.
Responsibilities will include but are not limited to:
• You will lead and manage analytical activities within a global project team (e. g. control strategy, specification setting strategy, method development, validation, stability and release testing.
• Writing of analytical source documents (e.g Analytical methods, Specifications, Validation reports, Stability reports)
• You are responsible to provide valuable input to the analytical CMC documents and support regulatory submissions
• Prepare analytical project plans and be accountable to meet quality, timelines and budget for assigned projects.
• Manage interactions and contribute to a high level of collaboration with internal and
• Leading outsourced analytical activities at CROs / CDMOs and contribute to manage the external partnership.
What you'll bring to the role:
• PhD in analytical chemistry or equivalent and a minimum 5 years' experience in the pharmaceutical industry in analytical development, preferable in late phase development for sterile parenteral products. Experience in Oligonucleotides analytic is a plus.
• Proven knowledge in late phase parenteral development and filings
• Proven leadership experience in managing development projects, ideally in a global matrix environment.
• Excellent understanding and awareness of regulatory guidelines for analytical development.
• Collaborative spirit, self-driven attitude, high level of learning agility are key attitudes
• Strong quality focus and experience in a cGMP environment.
• High level of motivation, excellent collaborative spirit and agility are key elements to our success
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. 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!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.
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:
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