scientist – early product development and manufacturing

• MSc or BSc in pharmacy/engineering or extensive GMP-manufacturing experience from the pharmaceutical industry
• Excellent collaboration, communication, and planning skills
• Strong sense of responsibility, teamwork and delivery focus
• Strong verbal and documentation skills in English
• Experience from pharmaceutical development or working in a manufacturing or supply chain organisation and knowledge of GMP is a merit for this role.
• Keen interest to learn and operate complex manufacturing equipment

As part of the EPDM manufacturing unit, you will work in a GMP (Good Manufacturing Practice) environment, contributing to the delivery of clinical results. Your role will focus on the manufacturing of drug product, with responsibilities including timely manufacture of various drug products, working with practical hands-on processes in our GMP facilities, monitoring regulatory requirements, supporting documentation activities, and driving initiatives to improve flexibility and productivity. As we are investing in innovative technology, among others within Continuous manufacture, we need to expand knowledge and competence in this area. Depending on prior experience and interest this role could be more adapted to this area.

Accountabilities include:

• Work with practical hands-on processes in our GMP facilities following manufacturing batch records and perform transactions in material management systems.
• Assume responsibilities toward timely manufacture of various drug products in line with the plans agreed within EPDM and surrounding stakeholders.
• Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
• Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinical manufactures.
• Support documentation activities, e.g. by authoring manufacturing batch records, taking part in deviation investigations, authoring SOPs, and other guidance documents, change control processes etc.
• 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 our customers and patients.

Deadline 2024-03-22 - the selection process and interviews will be ongoing, so please apply as soon as possible!