About this role
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 Key Responsibilities Responsible to develop and validate robust analytical methodologies applied to innovative Oligonucleotides therapeutics. Strong experience in various chromatography techniques is a pre-requisite.
Experience in mass spectrometry applied to biological molecules would be an asset. Responsible to design, plan, conduct, interpret and report analytical activities for DS and/or DP applying state of the art analytical science and technologies (e.g., analytical method developments/validations/transfers/stability/release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards. Contribute to the planning and execution of experiments in the lab for assigned projects (for e.g., scheduling of activities in the lab, experimental overview, data evaluation).
Author analytical documents supporting the analytical and the global project strategies based on project phase. Contribute to strategic decisions: design, plan and execute. Support the elaboration of analytical documents for handover to internal and external partners (for e.g., including Health authority questions /CMC modules / Manufacturing & supply operations etc.).
Accountable to share best practices, bring strong scientific and technical expertise within the analytical project sub team, analytical scientists and across the organization. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines and exhibit strong team spirit and promote knowledge exchange. Embrace the Novartis Values & Behaviors, coach and mentor project team members and other associates.
Contribute to shaping the Oligonucleotide lab further, alongside experienced experts and scientists and prepare the lab for Oligonucleotide analytics. Essential Requirements: PhD in Analytical Chemistry (or equivalent) with a minimum of 5 years of experience in pharmaceutical analytical development. Strong expertise in oligonucleotide analytics.
Proven expertise in liquid chromatography separation techniques, including RP, IEX, and HILIC (mandatory). Experience in mass spectrometry, including mass confirmation, impurity quantification, and sequencing (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