Associate Principal Scientist (Analytical)

Responsibilities

• ● 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.
• ● The role holder is responsible for a commercial product or group of commercial products related to the Analytical subject matter area, including analytical sciences and analytical technologies.
• ● The role holder is 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.
• ● The role holder leads the review of analytical methods performance via appropriate dashboards to ensure product and methods robustness across the QC network.
• ● The role holder supports the definition of analytical standards impacting commercial products specific to regulatory expectations and good business or quality standards, including pharmacopeial standards.
• ● The role holder provides training in subject matter expertise areas.
• ● The role holder develops and manages a prioritized portfolio of project activities, with appropriate demand and supply oversight.
• ● The role holder maintains a technical support model with outstanding customer service for all AZ manufacturing sites and external manufacturing/testing partners.
• ● The role holder leads and assesses the 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.
• ● The role holder develops solutions to a diverse range of problems requiring complex judgements based on highly developed levels of conceptual thought, strategic vision, and analysis.
• ● The role holder provides analytical technical leadership to support product supply strategy projects and business continuity plans through delivery of the drug product control strategy and product quality risk management activities throughout the lifecycle.
• ● The role holder is 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.
• ● The role holder supports 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.
• ● The role holder manages product knowledge throughout the lifecycle.
• ● The role holder maintains technical knowledge in the 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.
• ● The role holder authors, reviews, and renews regulatory files and responds to questions.