Jobs / China / Astrazeneca Pharmaceuticals Lp
Senior Scientist (Analytical)
Astrazeneca Pharmaceuticals Lp · 🌍 China - Wuxi
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About the role
The role holder is responsible for providing expert technical support related to Analytical Sciences to commercial products manufactured internally at AZ sites and externally at contract facilities. This role will not have direct reports. Specific Responsibilities include: · Responsible expert for a commercial product or group of commercial products related to the Analytical subject matter area (including analytical sciences and analytical technologies). · Responsible for analytical lifecycle activities to ensure testing methods, drug product specifications and drug product control strategies are and remain fit for purpose and aligned with technology advancements. · Leads the review of analytical methods performance via appropriate dashboards to ensure product and methods robustness across the QC network. · Supports the definition of analytical standards impacting commercial products specific to regulatory expectations and good business or quality standards (including pharmacopeial standards). · Provides training in subject matter expertise areas. · Develops and manage a prioritized portfolio of project activities, with appropriate demand and supply oversight. · Maintains a technical support model with outstanding customer service for all AZ manufacturing sites and external manufacturing/testing partners. · Leads and assess impact of complex technical improvements or change activities assuring product and methods performance and robustness, including extractables and leachable assessments, nitrosamines risk assessments and risk assessments of elemental and organic impurities. · Develop solutions to a diverse range of problems requiring complex judgements based on highly developed levels of conceptual thought, strategic vision and analysis. General Responsibilities include: · Provision of analytical technical leadership to support product supply strategy projects (sourcing, asset transfers, capacity expansion, etc.) and business continuity plans through delivery of the drug product control strategy, and product quality risk management activities throughout the lifecycle. · Responsible for the analytical technical support during the transfer of established products within sites and to external manufacturing partners including support for equivalency determination as applicable. · Support complex technical improvements or change activities assuring product performance and analytical methods robustness, including extractables and leachable assessments, nitrosamines risk assessments and risk assessments of elemental and organic impurities. · Management of product knowledge throughout the lifecycle. · Maintain technical knowledge in area of subject matter expertise including up to date advances in new regulations and technologies to aid in the improvement of pharmaceutical processes and or analytical methods. · Regulatory file authoring, review, license renewals and response to questions. · Support for drug product PPQ programs in the support of transfer and change activities. · Provision of technical problem-solving expertise to aid in the resolution of manufacturing/method/formulation issues & complaints impacting supply or manufacturability. The role holder will: · Create an effective partnership, manage expectations and resolve issues positively and in the best interest of AZ. · Ensure that all work is carried out in compliance with AstraZeneca and external regulatory policies and standards. · Continuously improve in competence, scientific excellence and innovation. · Operate at the highest level of risk management. · Be an excellent communicator with strong interpersona