Novartis seeks a Senior Expert Analytical Science in Basel to lead analytical activities for oligonucleotides, ensuring rigorous characterization and compliance from discovery through commercial production.
This position sits within the Analytical Research & Development team under Technical R&D. The role focuses on characterizing and analyzing drug substances and products throughout their lifecycle, from early discovery stages to full-scale commercial manufacturing.
Responsibilities
- Design, conduct, and document analytical studies for oligonucleotide drug substances and products using advanced scientific methods.
- Identify technical and GMP-related challenges, develop innovative solutions, and report critical findings to project leadership.
- Share expertise and promote best practices across analytical teams and the broader organization.
- Develop and review analytical documentation, including methods, specifications, validation reports, and stability data, while aligning with global project strategies.
- Plan and manage laboratory experiments, including scheduling, monitoring, and data interpretation.
- Mentor laboratory staff and provide scientific guidance to support team development.
- Lead investigations into technical deviations, out-of-specification results, and out-of-trend data, recommending corrective and preventive actions.
- Contribute to CMC documentation and support regulatory submission processes.
- Assist during audits and health authority inspections to ensure compliance and minimize findings.
- Adhere to standard operating procedures, GMP, GLP, quality management, and safety guidelines.
- Collaborate effectively with cross-functional teams and encourage knowledge sharing.
Requirements
- PhD with at least three years of relevant experience, or a Master's degree with a minimum of ten years in the pharmaceutical sector.
- Demonstrated expertise in oligonucleotide analytics.
- Strong proficiency in laboratory management and analytical techniques such as HPLC, UV-spectroscopy, and titration.
- Advanced skills in scientific and technical documentation, including method development reports, stability studies, validation documents, and IND IMPD modules.
- Solid understanding of quality principles, GMP, and regulatory expectations in drug development.
- Ability to thrive in a fast-paced, dynamic work environment.
- Strong coordination, communication, teamwork, self-motivation, and adaptability skills.
- Fluent proficiency in English, both written and spoken.
Nice to have
- Experience with antibody-oligonucleotide conjugates.
- Familiarity with mass spectrometry applications for oligonucleotide therapeutics.
What the company offers
- Annual base salary ranging from CHF 93,800 to CHF 174,200.
- Performance-based bonus tied to specific performance metrics.
- Comprehensive insurance, retirement plans, wellbeing resources, and global recognition programs.
- Flexible and hybrid working arrangements where feasible.
- Minimum of 14 weeks of paid parental leave.
About the company
Novartis is dedicated to reimagining medicine together, fostering a collaborative environment focused on advancing healthcare through innovative scientific solutions.
- Commitment to reimagining medicine together.
- Focus on collaborative scientific advancement.
- Support for employee wellbeing and professional growth.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.