Senior CMC Project Leader
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
Pharmaceutical Technology and Development (PT&D) is the bridge that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices for new medicines and providing expert technical support to all AZ's commercial drug substances and products to ensure we successfully supply medicines to patients.
We are now looking to hire a Senior Project Leader or Project Leader, depending on your background, to join our Chemistry Manufacturing and Controls (CMC) Team within PT&D.
As a Senior CMC Project Leader/CMC Project Leader you are accountable for the development of robust CMC project strategies and efficient delivery of one or several R&D development projects (typically from Ph2b) and/or commercial products where the focus is maximizing the Brand Value. You will be accountable for the CMC contribution when taking projects and portfolio through key business investment decision points, transfer to Operations and CMC related contributions to LCM (Life cycle management).
In this role you will primarily lead projects in the Biopharmaceutical Therapeutic Area (Respiratory, Inflammatory, Autoimmunity (RIA) and Cardiovascular, Renal, Metabolism (CVRM)) but may also be involved in other TA projects (e.g. Oncology).
You will represent PT&D and be a member of the Global Project Team (GPT), working collaboratively in a cross-functional and international environment to influence the development of AZ's development and commercial drug portfolio. You will be representing PT&D when projects interact with key governance bodies (ESPC, LSPC etc) and is expected to consistently demonstrate excellent communication skills and influence with stakeholders in these forums in a way that creates value for AZ. You will also lead the Pharmaceutical Project Team, with representatives from technical functions mainly but not exclusively from PT&D.
Accountabilities include delivering all the CMC related activities associated with Development of New Product (e.g. overall development and technical strategy, clinical trials applications), Business development activities (e.g. divestments, partnering, in-licensing) as well as Life Cycle Management for Commercial Products (e.g. new Clinical studies, filing in new markets, new formulations or devices, Cost of Goods reductions). The role involves a diverse range of problems/opportunities requiring complex judgements and solutions based on highly developed levels of conceptual thought and strategic vision and analysis.
Education, Experience and Capabilities
* Scientific degree (or equivalent) and a good working knowledge of a CMC organisation.
* Global drug development and clinical/commercial supply chain experience with business enterprise mindset and ideally good knowledge of the broader business especially development, commercialization, post-launch technical support and lifecycle management
* A good working knowledge of project leadership approaches within the pharmaceutical industry and experience from working with projects from phase II through commercialisation and LCM. Preferably will have experience from other areas than CMC.
* Understanding of at least one AZ disease area preferably RIA and/or CVRM.
* Track record of Ability to identify and progress innovative approaches, constructively challenging the status quo to achieve best outcome for the project/brand and AZ
* Understanding of Regulatory requirements, the evolving landscape and the constraints/opportunities this presents
* Experience of cost management (resources and $) of larger scale projects.
* Strong credible leadership with enterprise mindset.
* Learning agility, networking & negotiation skills and collaborative approach.
* Excellent interpersonal, influencing and communication skills with ability to set clear direction and objectives for the team and to influence at a senior level in the organisation including Governance groups (GPT/ESPC/LSPC/TALT/Supply Committee and beyond)
* Capable of managing the responsibilities for a diverse range of activities and projects acting as the key sponsor for projects and programmes supporting their project/product portfolio.
* Possess strength and independence of viewpoint and be willing to challenge others in senior roles when appropriate
* Ability to develop & implement end-to-end Pharmaceutical strategy across all CMC areas (API, DP, etc.) aligned with the overall GPT strategy and clinical/commercial supply
This is an exciting opportunity for professional growth in areas of drug development, science, and leadership. If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.
For more information contact Petra Edwards, Head of Project Leadership, PT&D at
Welcome with your application, no later than November 20, 2019
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-10-29ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-11-12
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-064588".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 4891735
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