QC Technical Support Manager

Employer
Location
Liverpool, USA, New York
Salary
Negotiable
Posted
Oct 18, 2017
Closes
Nov 17, 2017
Ref
R-015661
Contact
AstraZeneca
Contract Type
Full Time

Title: QC Technical Support Manager

Location: Liverpool, UK

Salary: Competitive

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.

The QC department is now looking to appoint a Technical support manager for the team. This is an important, exciting and highly visible role for the site. In this role, you will be responsible to lead the QC team and business processes and leadership of non-core testing activities within the Quality Control department and laboratories at the UK Vaccines Manufacturing Facility. You will be accountable for delivery of all activities in their area and development of a capable, motivated, informed effective and efficient workforce. You will provide operational and scientific guidance and oversight. You should be qualified to at least graduate level/or equivalent in a scientific discipline, with significant experience of working in a laboratory environment. Experienced people manager with extensive Good Manufacturing Practice. You must additionally have an understanding of the Quality Control function, Analytical Technology Transfer, Method Validation, and Computerised laboratory equipment validation. Successful applicant will also deputise for the head of QC on all scientific and technical areas when required.

Some of the other responsibilities are listed below:

  • You will be responsible for the Business Processes related to the QC department. You will insure that the business processes deliver the required performance of the QC department and are supportive of the overall site operation.
  • You will lead monitoring of QC assays and data to ensure assay performance and integrity and pro-actively managing the risk to product licensure and release
  • You will participate and lead continuous improvement activities to ensure that the analytical assays supporting Influenza Vaccine continues to be robust and are improved as technology continues to evolve
  • You will provide scientific and operational oversight and you will be leading the technical oversight of analytical technology transfers. In addition, you will conduct technical management of analytical technology transfers and review/ approve QC Technical Reports.
  • You will work with preparation of Test Method Qualification/Validation protocols and reports.
  • You will provide technical oversight of all QC activities associated with assay optimisation and automation.
  • You will work with the Site Management and Site Leadership Team (SLT) to develop strategic implementation plans with a 1 year horizon to support the Long Range Operating Plan (LROP).

Essential requirements

  • Qualified to degree level/or equivalent in a scientific discipline.
  • Extensive people management experience in a scientific environment.
  • Experience of FDA/MHRA regulatory audits.
  • Experience with specifying and validating process/Lab equipment and instrumentation, with process transfers.
  • Knowledge of ICH guidelines and experience in analytical validation.
  • Experience of a wide range of analytical techniques as applied to Vaccines and Monoclonal Antibodies
  • Experience in leading complex technical investigations
  • Experience and involvement in Operational excellence project and Six Sigma / Lean manufacturing initiatives
  • Strong technical writing, with proven ability in generating complex reports

Desired Requirements

  • PhD in appropriate scientific discipline
  • Previous Biopharmaceutical industry experience.
  • Project management and influencing skills.
  • Situational leadership and coaching skills.
  • Knowledge of Computer Validation processes applicable to QC
  • A proven track record in delivering significant change projects in a QC environment is desirable

If you're inspired by the possibilities science holds to change lives, and thrive when making brave decisions then join us.

Open date: 17th October 2017

End date: 18th November 2017

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.

*LI-MEDI