Job ID
REQ-10054201
Jun 05, 2025
Switzerland
Summary
Location: Basel, Switzerland
Role Purpose: We are looking for an Analytical Project Leader to support Analytical Research & Development (ARD) in the area of Project Management. ARD operates within the Technical R&D department of Novartis Development, playing an essential role in the characterization and analysis of Drug Substances and Drug Products from the time compounds leave the discovery laboratories until they are transferred to Commercial Production. The ideal candidate will be a highly motivated and experienced Analytical Project Leader with expertise in Oligonucleotide analytics.
About the Role
Your main responsibilities include:
- Serving as a member of a global CMC subteam responsible for leading the technical development of Drug Substance and Drug Products from early to late-phase clinical development.
- Managing analytical activities within a Technical CMC project team (e.g., defining control and specification setting strategies for Drug substances and Drug products of small molecule new modalities, such as xRNAs).
- Leading an analytical subteam, preparing analytical project plans, and ensuring compliance with quality standards, timelines, and budget for assigned projects.
- Accurately forecasting FTE and cost demands for your assigned projects.
- Issuing analytical source documents (e.g., Specifications, Validation reports, Stability reports, etc.) in a timely manner.
- Providing scientific inputs 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 managing external partnerships.
Educational Background
- Desirable: PhD in Analytical Chemistry or equivalent with a minimum of 5 years of experience in the pharmaceutical industry as a project leader in analytical development, preferably for sterile parenteral products. 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 within a global matrix environment.
- Strong understanding 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, demonstrating a willingness to go the extra mile.
- Broad scientific knowledge in chemistry, pharmaceutical, or analytical sciences, with the ability to perform in a dynamic environment.
- Excellent scientific and technical writing skills.
- Proficient in utilizing novel digital tools to enhance productivity in a global project management context.
- Proven ability to guide and coach colleagues effectively.
- Excellent communication skills and ability to serve as a role model.
- Fluent in English (both written and spoken); proficiency in German or French is a plus.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams that represent the patients and communities we serve.
Accessibility and Accommodation
Novartis is dedicated to working with and providing reasonable accommodation to all individuals. If you need assistance regarding accommodation for a medical condition or disability during the recruitment process, please email inclusion.switzerland@novartis.com and specify your request along with your contact information. Please include the job requisition number in your message.
How to Apply
Apply online using the form below. Only applications matching the job profile will be considered.
Why Novartis
Helping people with diseases and their families takes more than innovative science. It requires a community of intelligent, passionate individuals like you, collaborating, supporting, and inspiring one another to achieve breakthroughs that transform patients' lives. Are you ready to create a brighter future together? Learn more here.
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Benefits and Rewards
Explore our employee handbook to discover all the ways we support your personal and professional growth: Learn about our benefits and rewards.
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