Are you ready to make a significant impact on the development of new medicines?

Join us at AstraZeneca's Early Product Development and Manufacture (EPDM) unit in Gothenburg, Sweden. We are accountable for delivering a vast portfolio of early investigational medicinal products, supplying different types of clinical trial material to studies across the globe. This is your chance to explore and innovate in our dynamic environment!

This is an exciting opportunity to join our Pharmaceutical Sciences department which 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 role will be offered at Scientist level.

About the position

As part of the EPDM manufacturing unit, you will work in a GMP (Good Manufacturing Practice) environment, contributing to the delivery of clinical results. Your role will focus on the manufacturing of drug product, with responsibilities including timely manufacture of various drug products, working with practical hands-on processes in our GMP facilities, monitoring regulatory requirements, supporting documentation activities, and driving initiatives to improve flexibility and productivity. As we are investing in innovative technology, among others within Continuous manufacture, we need to expand knowledge and competence in this area. Depending on prior experience and interest this role could be more adapted to this area.

Responsibilities

• Work with practical hands-on processes in our GMP facilities following manufacturing batch records and perform transactions in material management systems.
• Assume responsibilities toward timely manufacture of various drug products in line with the plans agreed within EPDM and surrounding stakeholders.
• Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
• Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinical manufactures.
• Support documentation activities, e.g. by authoring manufacturing batch records, taking part in deviation investigations, authoring SOPs, and other guidance documents, change control processes etc.
• Assess records and report manufacturing and validation data accurately according to GMP.
• Ensure that SHE (Safety Health and Environment) and GMP standards are upheld and ensure AZ Policies and Standards are understood and followed.
• Be entrepreneurial and drive initiatives to further improve flexibility and productivity, resulting in shorter lead times or increased value for our customers and patients.

Your profile

Do you have the essential qualifications for these roles?

We are looking for a Scientist with excellent collaboration, communication, and planning skills with a strong sense of responsibility, teamwork and delivery focus.

• MSc or BSc in pharmacy/engineering or extensive GMP-manufacturing experience from the pharmaceutical industry
• Excellent collaboration, communication, and planning skills
• Strong sense of responsibility, teamwork and delivery focus
• Strong verbal and documentation skills in English
• Experience from pharmaceutical development or working in a manufacturing or supply chain organisation and knowledge of GMP is a merit for this role.
• Keen interest to learn and operate complex manufacturing equipment

About the organisation

This position is a consultant assignment at AstraZeneca for 6 months, with a chance of extension. During this time you will be employed by QRIOS Life Science & Engineering.

QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER.