Role Purpose: This position defines, leads, and manages the analytical project strategy, including the overall analytical control strategy for Drug Substance(s) and Drug Product(s). It aligns with the overall CMC project development plan, ensuring high-quality analytical submission documents and ready-for-inspection status at all times. The role also involves supporting and coaching analytical team members, contributing to the overall Technical Research & Development strategy and objectives.
About the Role
As part of the Analytical Research and Development group, this new role is an exciting opportunity for you to make your mark. The position is located at the Novartis Headquarters in Basel within the Technical R&D (TRD) department of Global Drug Development.
Your Responsibilities
Your responsibilities include but are not limited to:
Formulating, developing, and driving an overall 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 intended for oral administration).
Leading and overseeing analytical activities throughout drug development within a global project team, such as specification setting, method development and validation, stability, and release testing. Activities may cover pre-clinical support, early/late phase clinical development, as well as transfer to commercial operations and registration.
Being a core member of the technical development sub-team, representing Analytical Research & Development; co-owning the technical development in partnership with Chemical and Pharmaceutical Development; contributing actively to the formulation of 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 while defining clear analytical project plans.
Managing interactions with internal and external stakeholders, including potential outsourced activities.
Proactively identifying potential 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 and internal and external audits.
Supporting analytical project teams with quality awareness, strategic input, scientific, and technical expertise in a phase-dependent manner.
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.
Minimum 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 and 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).
Able to perform effectively in a highly dynamic environment.
Apply Online
To submit your application, please apply online using the form below. Only applications matching the job profile will be considered.
Commitment to Diversity and Inclusion
Novartis is dedicated to fostering an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.
Accessibility and Accommodation
For individuals requiring reasonable accommodation due to a medical condition or disability during the recruitment process, please contact us at . Include the job requisition number in your message for reference.
Why Novartis
Helping people with diseases and their families demands more than innovative science; it requires a community of smart, passionate individuals like you. By collaborating, supporting, and inspiring one another, we can achieve breakthroughs that transform patients' lives. Are you ready to work together to create a brighter future?
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Benefits and Rewards
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Division: Development
Business Unit: Innovative Medicines
Location: Switzerland
Site: Basel (City)
Company / Legal Entity: C028 (FCRS = CH028) Novartis Pharma AG