AdressAre 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 or Senior Scientist level, depending on your background and experience.
What you will do
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.
Accountabilities include:
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.
Essential requirements
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
Keen interest to learn and operate complex manufacturing equipment
Desirable for the role
Experience from pharmaceutical development or working in a manufacturing or supply chain organisation
Experience from sterile manufacture
Experience with material management systems
Ability to author manufacturing batch records, SOPs, and other guidance documents
Experience with deviation investigations and change control processes
Familiarity with SHE standards
Why AstraZeneca
At AstraZeneca, we follow the science to explore and innovate. We are unlocking the power of what science can do, working towards treating, preventing, modifying and even curing some of the world's most complex diseases. If you're driven by curiosity and courage, inspired by the possibility of doing things that have never been done before, this is the place for you.
So, what’s next? We welcome your application (including CV and cover letter), no later than April 7th, 2024.
Additional information
Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
About BioPharmaceuticals R&D: https://www.astrazeneca.com/r-d.html
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
