450! The number of Analytical Research & Development (ARD) employees globally. ARD sits within the Global Technical R&D department of Global Drug Development.
ARD 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 with a strong background and experience in Early Phase Development to join our team.
Your responsibilities will include, but are not limited to :
Lead and manage analytical activities within a global project team (e. g. contribute to the technical development plan, lead the specification setting strategy, method development and validation, stability and release testing.
Design, plan, perform, interpret and report results of scientific experiments for the development and preparation and timely delivery of drug substances (DS) and drug products (DP).
Write analytical source documents (e.g Analytical methods, Specifications, Validation reports, Stability reports) and provide input to CMC documents to support regulatory submission.
Prepare analytical project plans and be accountable to meet quality, timelines and budget for assigned projects.
Manage interactions with internal and external stakeholders, including outsourced activities to CROs.
Minimum requirements :
What you’ll bring to the role :
PhD in analytical chemistry or equivalent and a minimum 3 - 5 years’ experience in the pharmaceutical industry in analytical development, preferable in early development for sterile products and oligonucleotides.
Proven leadership experience in managing development projects, ideally in a global matrix environment.
Strong quality focus and experience in a cGMP environment.
Excellent understanding and awareness of regulatory guidelines for analytical development.
Profound knowledge in analytical sciences.
WHY CONSIDER NOVARTIS?
750 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 empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.
Some restrictions on flexible working options may apply and will be discussed during interview if applicable.