On Market Technical Leader
AstraZeneca Göteborg / Apotekarjobb / Södertälje
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AstraZeneca is now looking to hire an On Market Technical Leader to our Pharmaceutical Technology & Development (PT&D) Function. The role will be based at AstraZeneca Sweden operations in Södertälje, Sweden.
The PT&D (Pharmaceutical Technology & 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 within PT&D provides the expert technical support for AZ commercial products.
The On Market Technical function is a multi-skilled organisation who provide technical support and expertise related to formulation, manufacture, analytics, devices and testing. The key activities we deploy are technical expertise in the support of drug product improvement projects, changes, investigations, regulatory responses, new submissions, product robustness, risk and manufacturability. Under pinning the excellent technical support that drives robust product supply are processes & strategies targeting knowledge management, manufacturability, problem solving with alignment to the Global Product Supply Strategy. The On Market technical functions are a strong network of scientists located across the world at our key manufacturing, development sites and strategic hubs. We work closely with many technical functions across Operations providing the ability to drive science and build capability within our organisation and our ways of working.
Main Duties and Responsibilities
As an On Market Technical Leader you will be an 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, be a technical support and decision making in the event of product recall incidents and 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.
You will develop, manage & support a prioritized portfolio of project activities, with appropriate demand and supply oversight.
Be 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.
You will 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.
You will maintain technical knowledge in Analytical Methods & techniques expertise including up to date advances in new technologies to aid in the improvement of pharmaceutical methods and provide support for regulatory file authoring, review, license renewals and response to questions.
You will identify cross product or brand challenges or opportunities for commercial drug products. Leadership of technical strategic initiatives, networks or forums within the organisation.
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 with ~7+ years of relevant pharmaceutical industry experience) post degree or PhD level with 7+ years of experience post degree in an appropriate discipline such as Chemistry, Pharmacy, Pharmaceutical Sciences and have professional credibility within the business and industry.
• Have understanding of a broad range of Analytical techniques (standard and non standard)
• Have significant experience analytical method, development, validation, equipment and method capability and performance understanding.
• Have significant experience of CMC elements of commercial product requirements - development pharmaceutics, process establishment and optimisation, control of drug products, biopharmaceutics, stability, packaging and commercial manufacturing & validation.
• Have a thorough understanding of principles, applications and management of SHE and cGMP.
• 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.
• Experience in or exposure to multiple disciplines in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
• Have previous experience and training in Lean and six sigma, problem solving tools and have experience in data analysis and interpretation.
• Have strong leadership skills and behaviours with demonstration of being able to work across different functions
If you are interested, apply now!
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We're inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines - strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You'll be part of a team that's rolling back the frontiers of science to turn yesterday's impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients - and in return, we'll help you develop way beyond what you thought possible.
Publiceringsdatum2017-09-25Så ansöker duSista dag att ansöka är 2017-10-08
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Göteborg
AdressAstraZeneca Göteborg
Karlebyhus, Astraallén
15185 Södertälje
KontorsadressKarlebyhus, Astraallén
Jobbnummer 3715965
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