Personality / Commitment
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.
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 units 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 Phase I and II). We are supplying 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 the patient. In short, we are the first in line to manufacture what could improve the lives of numerous patients around the globe
Job / Skills
Within the EPDM manufacturing Units, 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 lead a group of assigned persons through a manufacture campaign.
• Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinicl manufactures.
• Author Master Manufacturing 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 driving initiatives to further improve flexibility and productivity, resulting in shorter lead times or increased value for customer.
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 or experience from pharmaceutical development or working in a manufacturing or supply chain organisation and knowledge of cGMP is required for this role. 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.
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams! As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.
We believe in growing together!