Analytical Expert

vor 3 Wochen

Basel, Schweiz Novartis Vollzeit

OverviewAnalytical Expert role at Novartis. This is a temporary contractor opportunity through Magnit Global to support Analytical Research & Development (ARD) in the Global Technical R&D department, focused on characterization and analysis of Small Molecule Drug Substances and Drug Products. Expertise in parenteral development, RLT, peptide analytics and parenteral dosage form is required.ResponsibilitiesPlan, interpret and report results of scientific experiments for timely supply of drug substances (DS) and drug products (DP).Write & review analytical documents (Analytical methods, Specifications, Validation reports, Stability reports, Batch records for stability and release testing) and align activities within a global project team.Drive method development for peptide drug substances and RLT Drug product.Manage interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance as necessary.Identify scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team.Work according to SOPs, GMP, Quality Directives, Health and Safety and internal Novartis guidelines.Provide input to analytical CMC documents and support regulatory submissions.Lead analytical activities including impurity profiling for RLT compounds (e.g., method development, validation, stability, and release testing).Provide scientific guidance to cross-functional and global project teams to drive the RLT portfolio.Collaborate effectively with project teams and stakeholders; maintain a collaborative and proactive attitude.Maintain good understanding of regulatory guidelines for analytical development.What you’ll bring to the rolePhD in analytical chemistry or equivalentAt least 5 years of pharmaceutical industry experience with GMP activities for development or marketed productsExpertise in documentation writing (Stability Reports, Validation, IND/IMPD modules, etc.)Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences; ability to perform in a dynamic environmentAdvanced knowledge of laboratory/technical tools (e.g., HPLC, LC-MS, Quality management systems, statistical evaluation tools)Proficiency with commonly used software and computer toolsExcellent scientific/technical writing skillsWillingness to develop new methods and assess new analytical techniquesProven leadership in guiding and mentoring colleaguesStrong coordination skills, collaborative spirit, self-driven attitude, high learning agilityStrong quality focusExcellent communication and role model skillsFluent in English (oral and writing)DetailsWorkload: 100% (40 hours per week)Role type: OnsiteRequired start date: 1st December 2025Contract: 12 monthsEEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.Accommodation: If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com. #J-18808-Ljbffr

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