Job description
AstraZeneca (AZ) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AZ, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made... Visa mer
Job description
AstraZeneca (AZ) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AZ, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The arena
Pharmaceutical Sciences is accountable for the design and development of synthetic routes, preclinical and phase I/II formulations, analytical methods and CMC project leadership needed to support early clinical trials, encompassing both small molecules and new modalities such as microRNA, messenger RNA and antisense oligonucleotides, across the whole range of AZ’s therapeutic areas.
The manufacturing unit within Early Product Development and Manufacture (EPDM) in Gothenburg is accountable for manufacture of a vast portfolio of early investigational medicinal products (oral solution/suspension, parenteral solutions, capsules, tablets and inhalers), mainly for Phases I and II. We supply drug product to AZ clinical studies globally and are a vital part to enable early phase clinical trials, delivering a critical step on the path from idea to patient. In short, we are the first in line to manufacture what could improve the lives of numerous patients around the globe.
Responsibilities
Within the EPDM manufacturing unit, in the GMP (Good Manufacturing Practice) arena, you will make an important contribution in delivering clinical results in the development of new medicines. This role revolves around the manufacturing of drug product where all activities below will have a significant impact on the speed, quality and cost of the AZ development portfolio. We expect the successful candidate to:
Assume responsibilities toward timely manufacture of numerous drug products in line with the plans agreed within EPDM.
Focus on practical hands-on work in our GMP facilities.
Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinical manufactures.
Author manufacturing batch records together with other required documentation and setup transactions in material management systems. Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
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.
Being entrepreneurial and drive initiatives to further improve flexibility and productivity, resulting in shorter lead times or increased value for customer.
Qualifications
We are looking for a scientist with excellent collaboration, communication, and planning skills, balanced with the ability to work independently and hands-on with complex equipment. You will need a strong sense of responsibility, team work and delivery focus.
You have a MSc or BSc in Pharmacy, Engineering, or similar. Excellent documentation skills, both in English and Swedish is a requirement. 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 manufacturing or supply chain organisation and knowledge of cGMP is strongly advantageous for this role.
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.
Application
Application deadline: 2020-04-08, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.
For more information: Kerstin Karlsson, consultant manager,
[email protected] or Eleonor Ehrman, consultant manager, +4673-343 41 09.
About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!
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