Job ID
REQ-10054201
Jun 05, 2025
Switzerland
Summary
Location: Basel, Switzerland
Role Purpose:
We are seeking an Analytical Project Leader to support Analytical Research & Development (ARD) within the Technical R&D department of Novartis Development. This role is integral to the characterization and analysis of Drug Substances and Drug Products, overseeing their journey from the discovery laboratories to Commercial Production. The ideal candidate will be a highly motivated and experienced professional in oligonucleotide analytics.
About the Role
Your main responsibilities include:
- Acting as a key member of a global CMC subteam responsible for the technical development of Drug Substance 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, preparing analytical project plans, and ensuring adherence to quality, timelines, and budget for assigned projects.
- Forecasting FTE and cost demands for your assigned projects accurately.
- Issuing analytical source documents such as Specifications, Validation reports, and Stability reports in a timely manner.
- Providing scientific input to analytical CMC documents and supporting regulatory submissions.
- Collaborating with internal and external stakeholders in drug development and coaching analytical experts.
- Leading outsourced analytical activities at CROs/CDMOs and contributing to the management of external partnerships.
Educational Background
- Desirable: PhD in analytical chemistry or equivalent, with a minimum of five years of experience in the pharmaceutical industry in analytical development as a project leader, preferably in development for sterile parenteral products. Experience in oligonucleotide analytics is an advantage.
- Proven knowledge in early or late-phase parenteral development and filings.
- Proven leadership experience in managing development projects, ideally within a global matrix environment.
- Excellent understanding and awareness of regulatory guidelines for analytical development.
- Collaborative spirit, self-driven attitude, and a high level of learning agility are essential traits.
- Strong quality focus and experience in a cGMP environment.
- High intrinsic motivation to work with new development compounds, coupled with a commitment to going the extra mile for 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.
- Understanding of how to leverage novel digital tools to enhance productivity in a global project management setting.
- Proven experience 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 committed to creating an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities we serve.
Why Novartis
Helping people facing disease and their families requires more than innovative science; it demands a community of smart, passionate individuals like you. Together, we can collaborate, support, and inspire each other to achieve breakthroughs that transform patients' lives. Are you ready to create a brighter future together?
Learn more about our culture and values.
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Benefits and Rewards
Explore our handbook to discover the myriad ways we support your personal and professional growth:
Read our Benefits and Rewards Handbook
How to Apply
To apply online, use the form below. Please note that only applications matching the job profile will be considered.
Division
Development
Business Unit
Innovative Medicines
Location
Switzerland
Site
Basel (City)
Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to fostering an inclusive work environment and building diverse teams that truly represent the patients and communities we serve.