Technical Scientist/Senior Scientist - Aseptic Manufacturing

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!

The arena

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.

What You'll do
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. You will work as a member of a cross-functional team, with a large degree of independence. There is both scope and an expectation to build a range of accountabilities over time, in line with personal development.
This is a practical hands-on role where you will work in our GMP facilities, acting as aseptic operator and support the manufacturing of Clinical Trial Material. 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 are 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. You will also 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.

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.

Requirements for the role:

* MSc or BSc in Engineering or related field of study
* Experience of working in Aseptic/Sterile environment.
* Knowledge of cGMPs and FDA policies and procedures.
* Strong communication skills (verbal & written) in English.
* Excellent understanding of requirements from authorities.
* Familiar with the operation, maintenance and validation of processes and equipment such as:

* Aseptic Fill / Finish systems (vial and syringe)
* Water for injection / Purified Water production systems
* Autoclaves, isolators and gas biodecontamination systems (VHP)
* HVAC & Facility Management Systems
* Lyophilisation
* Cleaning and monitoring of pharmaceutical cleanrooms / equipment

We expect you to have a keen interest to learn and operate complex manufacturing equipment and develop your expertise in pharmaceutical process technology.

Experience from pharmaceutical development or working in a drug manufacturing / supply chain organisation and knowledge of cGMP is a merit for this role.

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!
Welcome with your application; CV and cover letter, no later than August 8, 2021
For more information please contact: Frederika Bramer, Team Manager at Frederika.Bramer@astrazeneca.com

Additional information
BioPharmaceuticals R&D: https://www.youtube.com/watch?v=pmFx_jr2eFo
Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg: https://www.movetogothenburg.com/
Culture and atmosphere of the Gothenburg site: https://www.linkedin.com/feed/update/urn:li:activity:6496327311678410752/