Scientist - Early product Development & Manufacture

Modis Life Science is looking for a scientist to a consultancy assignment at AstraZeneca in Gothenburg. The assignment is initially 12 months and as a consultant you will be hired by Modis. Send your application as soon as possible, no later than March 20th.

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.

This role will be focused on supporting technical development and GMP installation of Continuous Direct Compression (CDC) equipment. AZ Gothenburg are doing major investments bringing in new technology to enable continuous manufacture both for development and clinical manufacture. In this role you will be hands on testing out technical function and be a vital part supporting validation to required GMP level, predominantly working in the CDC project.

The project is highly cross functional and high paced to allow us to install and start using the equipment for clinical manufacture during this year (2020). Below are some of the key responsibilities highlighted.

We expect the successful candidate to:

• Participate in technical tests and validation of the CDC equipment (IQ/OQ/PQ)
• Support our validation managers in validation, writing and reviewing validation reports
• 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.