Quality Control Immunologist, AstraZeneca Sweden Biologics

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Main Duties and Responsibilities

Performs laboratory tests in accordance with the appropriate cGXP in order to produce reliable and precise data to support product release and scientific investigations. Immunological testing to include: Cell Based Bio-Assay and Potency Assays, ELISAs, Residual DNA, Host cell Proteins and supporting cell/tissue culture activities. The checking of temperature storage units and responding to excursions. Prepares specimens and samples for analysis. Writes and execution of key protocols and reports

Undertakes a variety of non-routine testing including qualification of critical reagents, method transfer and validation, complaint, experimental/validation work and analytical support to production. Performs routine tasks accurately and following strict methodologies and processes to carry out analyses. Performs data review/approval and data retention activities. Input data for trending purposes. Uses computers and performs mathematical calculations for the analysis of data and preparation of graphs, trends, etc. Records and as appropriate interprets results to present to senior colleagues.

Lead Quality Control investigations as required. Provides support to functional and cross functional investigations when needed. Responds effectively to technical requests from the Quality Control function using expert knowledge of Quality Control instrumentation and methodology to troubleshoot, root cause and solve problems in order to minimise down-time.

Liaises with engineers and service providers in order to maximise knowledge and availability of equipment. Participates in local LEAN processes and consistently seeks opportunities for continuous improvement. Provides support to regulatory inspections with direct involvement as appropriate. Will be responsible for buddying and the practical training of new starters.

Constructs, maintains and operates standard laboratory equipment. Ensures the laboratory is well-stocked and resourced. Keeps up to date with technical developments, especially those which can save time and improve reliability.

Follows and ensures strict safety procedures and safety checks. To participate in Company inter-departmental problem-solving and teamwork initiatives. To ensure the compliance of all laboratory procedures and personnel with Health & Safety Guidelines. Leads by example and acts as a Role Model for the function championing initiatives.

Essential Requirements

• Degree level or equivalent in immunology or a related discipline
• Experience in cell/tissue culture
• Experience of conducting Bioassay and ELISA testing
• Fluent in both Swedish and English

Desirable Requirements

• Experience in a Good Manufacturing Practice (GMP) environment/Good Laboratory Practice (GLP)
• Understanding of Quality Control testing techniques
• Previous Biopharmaceutical Industry experience

If you are interested, apply now!

Welcome with your application no later May 14th, 2017.

At AstraZeneca every one of our employees makes a difference to patient lives everyday. We have an exciting opportunity for you to join our new biologics manufacturing plant at Gärtuna, Södertälje. The purpose-built facility will supply the next generation of biological drugs from the AstraZeneca pipeline; supporting the acceleration of the biologics portfolio. The new manufacturing plant will focus on the filling and packaging of protein therapeutics for late stage clinical and commercial products.Sweden Biologics we work as partners in bringing life changing medicines to patients, sharing and benefiting from each other's strengths. Our team is made up of a Global network of individuals from our business.

We are looking to hire a Quality Control Immunologist to Sweden Biologics, the location of this role is at our new facility in Gärtuna. As Quality Control Immunologist you will perform laboratory operations including quality control testing on biological products by immunological methods in accordance with the appropriate cGXP. Have data review and approval authority. You will also maintain the cell culture program and participate in analytical technology transfers and validations and conduct trouble-shooting of laboratory equipment. You will report directly to the Quallity Control Manager

We are looking for you that have degree or equivalent in immunology or a related discipline. You also have experience in cell/tissue culture and experience of conducting Bioassay and ELISA testing.

If you are inspired by the possibilities of science to make a difference and ready to discover what you can do - join us!

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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Publiceringsdatum
2017-04-25

Så ansöker du
Sista dag att ansöka är 2017-05-14
Ange följande referens när du ansöker: R-006543
Klicka på denna länk för att göra din ansökan

Företag
AstraZeneca Södertälje

Adress
AstraZeneca Södertälje
Karlebyhus, Astraallén
15185 Södertälje

Kontorsadress
Karlebyhus, Astraallén

Jobbnummer
3458359

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