Senior Expert Science & Technology

Major accountabilities:

·       Provide scientific leadership for late-phase analytical method validation, ensuring regulatory compliance and successful delivery of drug development programs, with hands-on experience in New Chemical Entity (NCE).

·       Be responsible for optimizing and validating robust analytical methodologies for oral solid dosage forms. Strong expertise in chromatography, dissolution testing and statistical tools is required.

·       Design, plan, execute, interpret, and report analytical activities for drug substance (DS) and/or drug product (DP), applying state-of-the-art analytical science and technologies (e.g., analytical method development, validation, transfer, stability studies, release testing, and formulation development analytics) in accordance with agreed timelines and quality standards.

·       Contribute to the planning and execution of laboratory experiments for assigned projects, including activity scheduling, experimental design, data evaluation, and interpretation.

·       Author analytical documents that support analytical and global project strategies throughout the project lifecycle. Contribute to strategic decision-making through the design, planning, and execution of analytical activities.

·       Support the preparation of analytical documentation for handover to internal and external partners, including responses to health authority questions, CMC modules, and Manufacturing & Supply Operations requirements.

·       Share best practices and provide strong scientific and technical expertise within analytical project sub-teams, among analytical scientists, and across the broader organization.

·       Ensure compliance with applicable SOPs, GMP, GLP, Quality Management (QM), Health, Safety & Environment (HSE), ISRM, and Novartis guidelines.

·       Demonstrate a strong team spirit and foster knowledge sharing. Embrace Novartis Values and Behaviors while coaching and mentoring project team members and other associates.

·       Develop, mentor, and coach scientific associates; present scientific and technical results internally; and contribute to scientific publications, presentations, and patent applications.

Essential Requirement

• Ph.D. in Analytical Chemistry (or a related discipline) with a minimum of 5 years of relevant experience, or a Master’s degree in chemistry, Pharmacy, or a related field with a minimum of 12 years of experience in pharmaceutical analytical development.

• Strong understanding of Analytical Control Strategy, method lifecycle management, CQAs, specifications, and regulatory requirements.

• Strong knowledge of USP/EP/JP dissolution requirements, with expertise in dissolution method development, optimization, validation, and application to formulation development, process understanding, and stability studies.
• Experience in mass spectrometry is considered an asset. Demonstrated contribution to scientific exchange and knowledge‑sharing groups within Novartis.
• Strong scientific capability with a proven track record of guiding and mentoring colleagues. Proficiency with software and digital tools, including MS Office, LIMS, and chromatography data systems (e.g., Chromeleon).
• Solid GMP experience (mandatory).Sound understanding of regulatory and quality expectations.
• Strong scientific foundation with excellent communication skills, including presentations and scientific/technical writing.