We are on the lookout for a talented Analytical Project Leader to join our Analytical Research & Development (ARD) team within the Technical R&D department at Novartis. This pivotal role focuses on project management, aiding in the characterization and analysis of Drug Substances and Drug Products from the point they leave discovery laboratories until they transition to Commercial Production. The ideal candidate will possess extensive experience in Oligonucleotide analytics and a passion for driving innovative solutions.
About the Role
Your key responsibilities include:
Being a member of a global CMC subteam responsible for the technical development of Drug Substances and Drug Products throughout early to late-phase clinical development.
Managing analytical activities within a Technical CMC project team, defining control and specification setting strategies for Drug Substances and Drug Products of small molecule new modalities (e.g., xRNAs).
Leading an analytical subteam, preparing analytical project plans, and ensuring adherence to quality, timelines, and budget for assigned projects.
Accurately forecasting FTE and cost demand for your assigned projects.
Providing scientific inputs to analytical CMC documents and supporting regulatory submissions.
Collaborating with internal and external stakeholders in drug development while coaching analytical experts.
Leading outsourced analytical activities at CROs/CDMOs and effectively managing external partnerships.
Educational Background
Desirable: PhD in analytical chemistry or equivalent with a minimum of 5 years experience in the pharmaceutical industry as a project leader, preferably in sterile parenteral product development. Experience in Oligonucleotides analytics is a plus.
Proven knowledge in early or late-phase parenteral development and filings.
Demonstrated leadership experience in managing development projects, ideally in a global matrix environment.
Strong understanding of regulatory guidelines for analytical development.
A collaborative spirit, a self-driven attitude, and a high level of learning agility are essential.
A strong quality focus and experience in a cGMP environment.
Intrinsic motivation to work with new development compounds, often going the extra mile for success.
Broad scientific knowledge in chemistry, pharmaceutical, or analytical sciences, with an ability to thrive in a dynamic environment.
Strong scientific/technical writing skills.
Familiarity with novel digital tools to enhance productivity in a global project management environment.
Proven leadership in guiding and coaching colleagues.
Excellent communication skills and the ability to serve as a role model.
Fluency in English (oral and written); proficiency in German or French is a plus.
Commitment to Diversity and Inclusion
Novartis is dedicated to fostering an outstanding, inclusive work environment with diverse teams that reflect the patients and communities we serve.
Accessibility and Accommodation
Novartis is committed to providing reasonable accommodation to all individuals. If you require accommodation for any part of the recruitment process, or need detailed information about the essential functions of a position, please send an email to Show e-mailm"> with your contact information and the nature of your request, mentioning the job requisition number.
Why Novartis?
At Novartis, we understand that helping those with diseases and their families requires more than just innovative science; it requires a community of passionate individuals. Join us in our mission to collaborate, support, and inspire one another to create breakthroughs that improve patient lives. Ready to create a brighter future together?
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