Senior Expert Science & Technology

Job Description Summary

-Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals. -Management Track -Lead a team for the development of pharmaceutical/biological/cell-gene therapies working in a multidisciplinary environment. Execute and support developing the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, NTO and NIBR plans
Lead and manage all project/local network activities and contribute to strategic decisions; design, plan, perform, -document and interpret scientific/developmental experiments or GMP testing or pilot plant processes for the preparation and timely delivery of generic products, processes or procedures within a multifunctional project team coordinated by a Project Manager/Leader; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.

 

Job Description

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.

 

Skills Desired

Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model