As a pivotal leader in the analytical project strategy, you will define and manage the overall analytical control strategy for Drug Substance(s) and Drug Product(s) in alignment with the broader CMC project development plan. Your expertise will ensure that project-specific high-quality analytical submission documents are always inspection-ready, while also supporting and coaching analytical team members to contribute effectively to the overall Technical Research & Development strategy and objectives.
About the Role
This is an exciting opportunity within the Analytical Research and Development group, located at the Novartis Headquarters in Basel, within the Technical R&D (TRD) department of Global Drug Development. We invite you to make your mark in this new role.
Your Responsibilities
Your responsibilities include, but are not limited to:
Formulating, developing, and driving an overarching science, quality, and regulatory-driven analytical project strategy, including contingency plans and risk evaluations during clinical development (API and formulated drug product, primarily small molecules designed for oral administration).
Leading and overseeing analytical activities throughout drug development within a global project team, such as setting specifications, method development and validation, stability and release testing. Activities will cover pre-clinical support, early/late phase clinical development, and transition to commercial operations and registration.
Being a core member of the technical development sub-team, representing Analytical Research & Development; co-owning technical development in collaboration with Chemical and Pharmaceutical Development; actively contributing to the overall CMC technical development plan and driving a state-of-the-art control strategy.
Accountability for meeting quality, timelines, and budget for assigned projects by defining clear analytical project plans.
Managing interactions with internal and external stakeholders, including potential outsourced activities.
Proactively identifying scientific, technological, and GMP gaps, proposing innovative solutions, and ensuring effective communication within and across units.
Providing input into CMC documents to support regulatory submissions.
Acting as the analytical project representative in peer reviews, as well as internal and external audits.
Supporting analytical project teams with quality awareness, strategic input, and scientific and technical expertise as appropriate for each phase.
Making significant contributions to advancing science, technology, and innovation within Analytical R&D.
What You'll Bring to the Role:
Minimum BS/MS in analytical chemistry with relevant industry experience; a PhD in analytical chemistry or equivalent is desirable.
A minimum of 3-5 years of experience in the pharmaceutical industry, preferably in analytical development and/or quality control.
Experience in managing projects, ideally in a global matrix environment.
Strong quality focus, with experience in a GMP environment.
Understanding of regulatory expectations and profound scientific knowledge in analytical development (e.g., chromatography, dissolution rate, titration, physical state, etc.).
Fluency in English (oral and written).
Ability to thrive in a highly dynamic environment.
Why Novartis
Joining Novartis means becoming part of a community dedicated to helping those affected by disease and their families. It takes collaborative and passionate individuals to create breakthroughs that change lives. Are you ready to create a brighter future together?
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Commitment to Diversity and Inclusion
Novartis is committed to fostering an exceptional, inclusive work environment with diverse teams that reflect the patients and communities we serve.
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