SCIENTIST – EARLY PRODUCT DEVELOPMENT & MANUFACTURE TO ASTRAZENECA

About AstraZeneca
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 solutions/suspensions, parenteral solutions, capsules, tablets and inhalers), mainly for phase I and II. We supply drug product to AZ clinical studies globally and are a vital part to enable 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. The role will be divided between manufacturing activities in our GMP facilities and validation.

The work within the field of validation includes for example purchase of new equipment or parts, validation review of GMP equipment, change management and other validation activities, assuring that we uphold GMP status of our equipment.

The manufacturing of drug product will focus on practical hands-on work in our GMP-facilities. Below are some of the key responsibilities highlighted.

We expect the successful candidate to:
- Write User Specification Requirements and drive purchase for new equipment or parts.
- Support our facility/validation managers in validation review.
- Assume responsibilities toward timely manufacture of numerous drug products in line with the plans agreed within EPDM.
- Rapidly develop strong competence within relevant process technologies, validation 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.
- Be entrepreneurial and drive initiatives to further improve flexibility and productivity, resulting in shorter lead times or increased value for customer.

Experience and 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. Excellent documentation skills, both in English and Swedish is a requirement.

You have a MSc or BSc in Pharmacy, Engineering, or similar. We expect you to have a keen interest to learn and operate complex manufacturing equipment and develop your expertise in pharmaceutical process technology and validation. Experience from pharmaceutical development or working in a manufacturing or supply chain organisation and knowledge of cGMP is strongly advantageous for this role. As is experience from validation.

What we offer you at ALTEN
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!