Technical Manager- Analytical Chemistry

Location: Södertälje / Gärtuna, Sweden

The PT&D (Pharmaceutical Technology and Development) Organization is responsible for drug product design, development and technical support for drug substance and products throughout the life cycle. The On Market Technical Functions provide the expert technical support for AstraZeneca commercial products. It is a multi-skilled organisation, which provides technical support and expertise related to drug product formulation, manufacture, process engineering, statistics, modelling, devices and testing. The key activities where we deploy our technical expertise are in the support of drug product improvement projects, changes, technology transfers, investigations, regulatory responses, new submissions, product robustness, validation, risk and manufacturability.

Main Duties and Responsibilities

* Responsible expert for a major commercial product or group of products expert related to the Analytical Chemistry - subject matter area.
* Provision of technical expertise & leadership to aid in the resolution of analytical - issues impacting supply and to drive proactive continuous improvement across the product control strategies.
* Responsible for the assessment of impact 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 preventive 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 eg 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 pharmacopeial standards).
* Provision of training in subject matter expertise areas.
* Coaching of technical experts across PT&D in analytical methodology subject matter areas.
* Identify cross product or brand challenges or opportunities for commercial drug products.
* Leadership of technical strategic initiatives, networks or forums within the organisation.
* Recognised externally as a technical leader the Analytical Chemistry field.
* Lead or influence Science and Technology strategy for analytical methodology.



Essential Requirements

* Have an excellent understanding of the overall drug development and commercialization process from development, launch and through life cycle management
* Likely to be educated to BSc or PhD level in an appropriate discipline and have professional credibility within the business and industry.
* Have in depth understanding of the analytical science discipline in relation to pharmaceutical drug development and supply.
* Experience in Operations and/or R&D with a track record of successful project leadership and delivery within a matrix organization.
* Evidence of excellent communication skills and build excellent relationships with customers.



Desirable Requirements

* Experience in managing technical issue resolution on a global scale.



If you are interested, apply now!



Welcome with your application no later than 23 September, 2018.



AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.