Job ID: REQ-10054201
Date: June 5, 2025
Location: Basel, Switzerland
Summary
We are seeking an Analytical Project Leader to bolster our Analytical Research & Development (ARD) team. ARD is a crucial part of the Technical R&D department at Novartis Development, playing an essential role in the characterization and analysis of Drug Substances and Drug Products from the moment compounds exit the discovery laboratories to their transfer to Commercial Production. We desire a highly motivated and experienced Analytical Project Leader with expertise in Oligonucleotide analytics.
About the Role
Your primary responsibilities will include:
- Being an integral member of a global Chemistry, Manufacturing, and Controls (CMC) subteam, responsible for leading 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, including defining control and specification setting strategies for Drug Substances and Drug Products of small molecule new modalities (e.g., xRNAs).
- Leading an analytical subteam while preparing analytical project plans and being accountable for meeting quality, timelines, and budget for assigned projects.
- Forecasting FTE and cost demands accurately for your assigned projects.
- Ensuring timely issuance of analytical source documents (e.g., Specifications, Validation reports, Stability reports, etc.).
- Providing scientific contributions to the analytical CMC documents and supporting regulatory submissions.
- Collaborating with internal and external stakeholders in drug development and mentoring analytical experts.
- Leading outsourced analytical activities at CROs/CDMOs and contributing to managing external partnerships.
Educational Background
- Desirable: PhD in analytical chemistry or equivalent and a minimum of 5 years of experience in the pharmaceutical industry in analytical development as a project leader, preferably in the development of sterile parenteral products. Experience in Oligonucleotide analytics is a plus.
- Proven knowledge in early or late phase parenteral development and filings.
- Proven leadership experience in managing development projects, ideally in a global matrix environment.
- Excellent understanding and awareness of regulatory guidelines for analytical development.
- A collaborative spirit, self-driven attitude, and high level of learning agility are essential.
- Strong quality focus and experience in a cGMP environment.
- High intrinsic motivation to work with new development compounds, where going the extra mile is key to success.
- Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, with the capability to perform in a highly dynamic environment.
- Strong scientific/technical writing skills.
- Understanding of how to leverage novel digital tools for enhanced productivity in a global project management environment.
- Proven leadership in guiding and coaching colleagues.
- Excellent communication and role-modeling skills.
- Fluency in English (both 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 and diverse teams that reflect the patients and communities we serve.
Why Novartis
Helping people with diseases and their families requires more than innovative science. It demands a community of intelligent, passionate individuals like you—collaborating, supporting, and inspiring each other to achieve breakthroughs that transform patients' lives. Ready to create a brighter future together?
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Benefits and Rewards
To learn about how we can support you in thriving both personally and professionally, please refer to our benefits handbook.
Application Process
Apply online using the form below. Please note that only applications matching the job profile will be considered.