Scientist– Early Product Development and Manufacturing

Job description
Scientist– Early Product Development and Manufacturing

At AstraZeneca, we unlock the power of What Science Can Do. Empowered to explore, every day we work towards our ultimate aim - treating, preventing, modifying and even curing complex diseases. Be part of the team where you are empowered to follow the science!

Pharmaceutical Sciences (PharmSci) is responsible for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities such as mRNA and oligonucleotides, across the whole range of AstraZeneca’s therapeutic areas.

The manufacturing unit within Early Product Development and Manufacture (EPDM) in Gothenburg is accountable for manufacture of a large and variable 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 patients around the globe.

We are now looking for a Scientist starting as soon as possible with the location Gothenburg, Sweden.

This is a consulting assignment with Randstad Life Sciences. Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities
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 various drug products in line with the plans agreed within EPDM and surrounding stakeholders.
Work with practical hands-on processes in our GMP facilities following manufacturing batch records and perform transactions in material management systems.
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.

In joining EPDM and PharmSci, you will be part of an amazing group of skilled and driven colleagues who truly embrace team spirit, who you will exchange knowledge and collaborate with on many levels in various contexts. This provides excellent opportunities for your professional development, and possibilities to take on further accountabilities in line with your personal growth.
Do you have the essential qualifications for these roles?

We are looking for a Scientist with excellent collaboration, communication, and planning skills with a strong sense of responsibility, team work and delivery focus.
Strong verbal and documentation skills in English 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. Experience from pharmaceutical development or working in a manufacturing or supply chain organisation and knowledge of cGMP is a merit for this role.

Qualifications
Requirements:
MSc in pharmacy/engineering and/or extensive GMP-manufacturing experience from the pharmaceutical industry.
Strong verbal and documentation skills in English is a requirement.
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 a merit for this role.

So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

About the company
About randstad life sciences
Randstad Life Sciences is specialized in competencies within Life Science. As a consultant with us, you get a competitive salary, benefits, and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Deadline: 2023-11-03, selection and interviews will be ongoing.
For more information: Please contact Katan Ali, katan.ali@randstad.se