Title: QC Biosafety Specialist
Location: Liverpool, UK
MedImmune is the worldwide biologics research and development arm of AstraZeneca. We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, infectious diseases and vaccines.
We are looking to recruit a Biosafety Specialist for the QC department to join the team in Liverpool. In this role, you will provide expert technical and analytical support to the Quality Control function and Site including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology. You will lead significant Quality Control investigations and change programs including introduction of new methods and technologies. You should be qualified to graduate level/or equivalent in a scientific discipline, with significant experience of working in a laboratory environment. You will have expert knowledge and understanding of their functional area and laboratory instrumentation, as well as Good Manufacturing Practice/Good Laboratory Practice. You must have an understanding of the Quality Control function, and its role & importance to the business.
Please note this position is a shift based position that operates on 4 on and 4 off basis.
Some of the other responsivities include:
- You will provide expert technical support to maintain cGMP testing in support of Out Of Specifications (OOS) investigations and Non-conformance investigations.
- You will review and monitor trending control data, lead and author significant Quality Control investigations.
- You will introduce and embeds new technology/systems into the Quality Control Function. You will also drive change management when necessary.
- You will lead/support method validation activities and the analytical technology transfer of Quality Control methodology into and out of Operations, including the design of transfer protocols and strategies.
- You will author and review of regulatory documents and submissions. You will also support and lead projects when necessary.
- Qualified to degree level/or equivalent in a scientific discipline
- Proven track record of working with cell lines, assay development and validation. Examples include: Invitro, In-vivo, PCR, Microplasma and RT assays
- Experienced Quality Control Analyst and a technical SME in a QC Discipline
- Lead Investigator expertise required
- Must have effective problem-solving skills
- Must have lead projects through completion
- Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice / Good Laboratory Practice
- Biopharmaceutical industry experience
- Project management and influencing skills
MedImmune’s dynamic environment fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. If you’re inspired by the possibilities science holds to change lives, and thrive when making brave decisions then join us.
Closing date: 19th February 2018
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.