Scientist - Drug Product Manufacture

Antal platser:
Yrkesbenämning: Biomedicinsk analytiker
Publicerad: 2020-01-14
Sista ansökningsdag: 2020-01-28
Stad: Göteborg
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. The role 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, and simultaneously lead and coordinate parallel manufacturing activities performed by assigned co-workers. * 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. Experience/requirements 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 in Pharmacy or engineering. Excellent documentation skills, both in English and Swedish is a requirement. You will need proven record of collaboration and team work skills. 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 highly advantageous for this role. More information For more information about the position please contact Kim Stockfelt at +46 31 776 10 00 or Oskar Hedberg at +46 31 77 62673. Welcome with your application no later than Monday the 27th of Jan 2020.

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