Job PurposeThe R&D Analytical Manager will lead an Analytical team involved in Method development and validation, Method Transfer and ICH stability studies for various stages of drug developmentKey Responsibilities• Define the analytical strategy for new and ongoing projects to ensure all project work is effectively and efficiently delivered on time according to project schedule • Prepare, review and approve protocols, reports and other associated project / GMP documentation ensuring the documentation are in compliance to internal and country specific regulations• Manage internal team resources/schedules ensuring adequate planning and resource allocation for assigned development projects • Identify technical problems/issues and develop solutions and fully implementing these solutions in agreement with Group Leader, Departmental Manager where appropriate• Manage, supervise, and approve any analytical activities outsourced to external labs or Contract Development and Manufacturing Organization• Ensure the R&D Analytical Laboratory is operated in a safe manner with full compliance to Standard Operating Procedures • Implement and monitor systems/processes within the Laboratory to ensure cGMP compliance and drive change where required to improve systems and processes• Take full responsibility for OOS/OOT/OOE investigations and ensure all investigations are conducted in a thorough and timely manner in accordance with procedures. Support Senior Analysts in setting investigation strategies and approve the design for investigations• Provide support to QA department during Audits (internal/external) and promptly complete all assigned actions from audits • Provide support (as required) to Regulatory department to respond to deficiency letters and to prepare the relevant documentation for dossier variation submission or scientific advice documentation preparation• Actively participate in any assigned Team Project as Analytical SME• Act as Due Diligence Advisor for CMC Module as required Prepare budget and review forecasts for analytical labsRequired Skills and Experience+8 years proven track record in analytical team/laboratory management including experience in analytical development and validation Experience and knowledge in ICH guidelines, stability data management, and cGMP.Proven experience in CMC pharmaceutical sciences focussed on analytical development.Technical CompetenciesKnowledge of analytical statistics tools and applications, perform trend analysis and evaluation.Experience with analytical techniques for small molecules required, including UPLC/HPLC, GC, KF, UV/Vis, and IR. Particle size analysis, dissolution testing, DSC, TGA, and XRPD are a plus. Knowledge of CMC regulation, with proven track record of deficiency letters management (analytical activities).Knowledge in formulation development science is a plus.Knowledge in LC/MS, Proteomics, and peptide analysis techniques and regulamentation is a plusRequired Behaviours and CompetenciesLeadership skills and strategic problem-solving ability; ability to predict issues and identify solutionsAbility to successfully participate within extended, global multinational project teams and handle multiple challenges under pressureSelf-directed and motivatedCollaborative and good team playerExcellent organizational and communication skills. Proactive management of multiple tasks of varying complexity simultaneously.Required LanguagesFluent English both spoken and written#LI-AS2