Location: Basel, Switzerland
We are currently seeking a highly motivated and experienced Analytical Project Leader to join our Analytical Research & Development (ARD) team within the Technical R&D department at Novartis. The ARD team plays a crucial 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.
Main Accountabilities:
- Serve as a member of a global CMC subteam responsible for leading the technical development of Drug Substances and Drug Products from early to late phase clinical development.
- Manage 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).
- Lead an analytical subteam, preparing analytical project plans to meet quality, timelines, and budget for assigned projects.
- Forecast FTE and cost demands accurately for assigned projects.
- Ensure the timely issuance of analytical source documents (e.g., Specifications, Validation Reports, Stability Reports, etc.).
- Provide scientific inputs to analytical CMC documents and support regulatory submissions.
- Collaborate with internal and external stakeholders in drug development and coach analytical experts.
- Lead outsourced analytical activities at CROs/CDMOs and contribute to managing external partnerships.
Ideal Background:
- PhD in analytical chemistry or equivalent with a minimum of 5 years’ 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 filing.
- Proven leadership experience in managing development projects, ideally in a global matrix environment.
- Excellent understanding of regulatory guidelines for analytical development.
- A high level of intrinsic motivation to work with new development compounds, demonstrating the willingness to go the extra mile.
- Broad scientific knowledge in chemistry, pharmaceutical, or analytical sciences with the ability to perform in a highly dynamic environment.
- Excellent communication and role model skills.
- Proficiency in using novel digital tools to enhance productivity in a global project management environment.
- Fluent in English (oral and written); proficiency in German is a plus.
Commitment to Diversity and Inclusion:
Novartis is dedicated to fostering an outstanding and inclusive work environment with teams that represent the diverse patients and communities we serve.
Accessibility and Accommodation:
Novartis is committed to providing reasonable accommodation for all individuals. If you require assistance due to a medical condition or disability during the recruitment process, please reach out for support. You can apply online using the form below. Only applications matching the job profile will be considered.