We are seeking an Analytical Project Leader to join our Analytical Research & Development (ARD) team within the Technical R&D department at Novartis. This pivotal role supports the characterization and analysis of Drug Substances and Drug Products from the initial stages in the discovery laboratories to their transition to Commercial Production. We invite motivated and experienced candidates with a focus on Oligonucleotide analytics to apply.
About the Role
Your main responsibilities include:
Being a proactive member of a global CMC subteam, leading the technical development of Drug Substance and Drug Products throughout various clinical development phases.
Managing analytical activities within a Technical CMC project team, including defining control and specification setting strategies for Drug substances and Drug products, especially for new small molecule modalities (e.g., xRNAs).
Leading an analytical subteam, preparing project plans, and ensuring adherence to quality, timelines, and budget for the assigned projects.
Forecasting FTE and cost demands accurately for your projects.
Issuing analytical source documents in a timely manner (e.g., Specifications, Validation reports, Stability reports).
Providing scientific input for analytical CMC documents and supporting regulatory submissions.
Collaborating with internal and external stakeholders in drug development and mentoring analytical experts.
Managing outsourced analytical activities at CROs/CDMOs while fostering positive external partnerships.
Educational Background
Desirable: PhD in analytical chemistry or equivalent with a minimum of 5 years of experience in the pharmaceutical industry within analytical development, preferably focusing on sterile parenteral products. Experience in Oligonucleotides analytics is an asset.
Knowledge in early or late-phase parenteral development and regulatory filings.
Proven leadership experience in managing development projects, ideally in a global matrix environment.
Strong understanding of regulatory guidelines for analytical development.
Collaborative spirit, proactive attitude, and high learning agility are essential qualities.
Focus on quality and significant experience in a cGMP environment.
High intrinsic motivation to work with new development compounds, requiring occasional extra efforts to ensure success.
Broad scientific knowledge in chemistry, pharmaceutical, or analytical sciences, with the ability to thrive in a dynamic environment.
Strong scientific and technical writing skills.
Ability to leverage novel digital tools to enhance productivity in global project management.
Proven leadership in guiding and coaching colleagues effectively.
Excellent communication skills and a role model for others.
Fluency in English (oral and written), with proficiency in German or French considered beneficial.
Commitment to Diversity and Inclusion
Novartis is dedicated to fostering an inclusive work environment and building diverse teams that reflect the communities and patients we serve. We believe that diversity drives innovation and contributes to better patient outcomes.
Accessibility and Accommodation
Novartis is committed to providing reasonable accommodations for individuals with medical conditions or disabilities. If you require assistance during the recruitment process, please reach out via email at Show e-mailm"> to discuss your needs. Please include the job requisition number in your message.
Why Novartis
Helping people facing health challenges requires more than innovative science; it demands a community of intelligent and passionate individuals. Together, we collaborate and inspire each other to achieve breakthroughs that make a difference in patients' lives. Ready to create a brighter future together?
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Benefits and Rewards
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