AstraZeneca Pharmaceuticals LP Global Technical Service Manager, AP region in Wuxi, China

The role of the Snr/Technical Manager – Analytical Chemistry has the following responsibilities:

  • • Responsible expert for a major Commercial Product or group of products expert related to the Analytical Method subject matter area.

  • • Provision of technical expertise & leadership to aid in the resolution of analytical method issues & complaints impacting supply.

  • • Responsible for the impact assessment and management of the decision making process across functions for issues spanning across sites and functions outside of PT&D.

  • • Provision of technical support and decision making in the event of product recall incidents

  • • Development of suitable corrective and preventative actions in support of investigations

  • • Provision of technical expertise to support product supply strategy projects (sourcing, asset transfers, capacity expansion etc) and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle.

  • • Develop, manage & support a prioritized portfolio of project activities, with appropriate demand and supply oversight.

  • • Responsible for the technical support during the transfer of established product methods within sites and to external manufacturing partners including support for equivalency determination as applicable.

  • • Lead, assess impact & support complex technical improvements or change activities assuring product performance.

  • • Management of product knowledge throughout the lifecycle.

  • • Responsible for method lifecycle activities to ensure equivalence across sites e.g. integrated method performance reviews, specifications, methods, processes.

  • • Drive standardisation & modernisation of analytical equipment across operations for key analytical methods and processes.

The role of the Snr/Technical Manager – Analytical Chemistry has the following responsibilities:

  • • Responsible expert for a major Commercial Product or group of products expert related to the Analytical Method subject matter area.

  • • Provision of technical expertise & leadership to aid in the resolution of analytical method issues & complaints impacting supply.

  • • Responsible for the impact assessment and management of the decision making process across functions for issues spanning across sites and functions outside of PT&D.

  • • Provision of technical support and decision making in the event of product recall incidents

  • • Development of suitable corrective and preventative actions in support of investigations

  • • Provision of technical expertise to support product supply strategy projects (sourcing, asset transfers, capacity expansion etc) and business continuity plans through delivery of the drug product control, manufacturability strategy and product quality risk management activities throughout the lifecycle.

  • • Develop, manage & support a prioritized portfolio of project activities, with appropriate demand and supply oversight.

  • • Responsible for the technical support during the transfer of established product methods within sites and to external manufacturing partners including support for equivalency determination as applicable.

  • • Lead, assess impact & support complex technical improvements or change activities assuring product performance.

  • • Management of product knowledge throughout the lifecycle.

  • • Responsible for method lifecycle activities to ensure equivalence across sites e.g. integrated method performance reviews, specifications, methods, processes.

  • • Drive standardisation & modernisation of analytical equipment across operations for key analytical methods and processes.

  • • Develop and maintain understanding of equipment vendor and academic landscape in relation to analytical sciences.

  • • Leads Global review of product performance via appropriate dash-boards/CPV assessments to ensure method robustness.

  • • Identify opportunities for method improvements.

  • • Maintain technical knowledge in Analytical Methods & techniques expertise including up to date advances in new technologies to aid in the improvement of pharmaceutical methods.

  • • Provide support for regulatory file authoring, review, license renewals and response to questions.

  • • Support for defining technical standards impacting commercial products specific to regulatory expectations and good business or quality standards (including pharmacopeia standards).

  • • Provision of training in subject matter expertise areas.

  • • Develops, implements, integrates and sustains new analytical requirements to enhance compliance in accordance with regulatory changes.

All these activities have a significant impact on the overall success of Operations by ensuring appropriate manufacturing and testing of AstraZeneca’s commercial products. MS&T secures availability of AZ’s products for the commercial organisation and patients, impacting on both financial and reputational aspects of the business.