OBS! Ansökningsperioden för denna annonsen har
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Arbetsbeskrivning
At AstraZeneca, we unlock the power of What Science Can Do. Empowered to explore, every day we work towards our ultimate aim - treating, preventing, modifying and even curing complex diseases. Be part of the team where you are empowered to follow the science!
Pharmaceutical Sciences is accountable for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities such as mRNA and oligonucleotides, across the whole range of AstraZeneca´s therapeutic areas.
The manufacturing unit within Early Product Development and Manufacture (EPDM) in Gothenburg, Sweden is accountable for manufacture of a vast portfolio of early investigational medicinal products. We are currently building a state of the art parenteral manufacturing asset. As part of this investment, we are now looking to strengthen our Parenteral Manufacturing & Technology Team.
The role
We are now seeking a new member to join our fantastic team, based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work.
What You'll do
In the role as Scientist/Senior Scientist, you will work as a member of a cross-functional team, both in groups and with autonomous tasks. You will be working in a highly regulated environment, ensuring compliance with Safety, Health and Environmental (SHE), current Good Manufacturing Practice (cGMP), and AstraZeneca standards at all times. There is both scope and an expectation to build a range of accountabilities over time, in line with personal development.
This is role involving significant amounts of hands-on tasks working in our GMP facilities, acting as R&D GMP operator manufacturing Clinical Trial Material within the areas of both oral solutions/suspensions and sterile manufacturing. As such you will need a strong technical competence, credibility and ability to give assured technical direction.
Through coaching and support you will develop an understanding of equipment, processes and automated system design and become an expert equipment user.
You will support documentation activities, e.g. by authoring manufacturing batch records, taking part in deviation investigations, authoring SOPs, change controls and other guidance documents, according to GMP. You are also expected to support initial production runs and then evaluate the efficiency of components, processes and equipment to initiate, develop and implement recommendations for improvements that will increase efficiency and effectiveness. Your role will also ensure equipment is validated and revalidated in a timely manner as well as create and execute validation protocols for equipment, including maintenance and upgrades.
With your great collaboration skills you'll ensure effective collaboration at relevant interfaces within EPDM, Development QA and other partners across the different therapy areas and R&D departments.
Do you have the essential qualifications for these roles?
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MSc or BSc in Engineering, Pharmacy or related field of study
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Experience of working in GMP manufacturing, ideally in an Aseptic environment.
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Knowledge of cGMP policies and procedures and understanding of requirements from authorities.
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Strong communication skills (verbal & written) in English.
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Familiar with the operation, maintenance and validation of processes and equipment such as:
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Aseptic Fill / Finish systems (vial and syringe)
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Water for injection / Purified Water production systems
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Autoclaves, isolators and gas biodecontamination systems (VHP)
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Lyophilisation
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Cleaning and monitoring of pharmaceutical cleanrooms and equipment
If your passion is science & technology and you want to be part of a team that makes a positive impact on patients' lives, then there's no better place to be. With us there are many opportunities to develop yourself and your career. From our diverse portfolio and teamwork, to our cutting-edge innovations - it's a place for lifelong learning.
So, what's next?
Are you already imagining yourself joining us? Good, because we can't wait to hear from you!
For more information about the position, please contact hiring manager Frederika Bramer via Frederika.Bramer@astrazeneca.com.
Welcome with your application (CV and cover letter) no later than June 5th. We will review the applications continuously so please apply as soon as possible.
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