Analytical Senior Scientist Biopharmaceuticals
AstraZeneca Mölndal / Biomedicinjobb / Mölndal
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Description:
Impact on business results
At Product Development (PD) Sweden, a sub-division of Pharmaceutical Development, we focus on drug delivery in the fields of inhalation, oral controlled and immediate Release and parenteral administration of new modalities such as peptides and polynucleotides.
In the area of new modalities we aim to strengthen our competence and analytical capability for biomolecules (e.g., proteins, peptides, DNA and RNA). We are now looking for an experienced scientist with a focus on analytical characterisation of biopharmaceuticals. The role covers development of various analytical methods from early preclinical phase to quality assessment including regulatory aspects of clinical products.
Accountabilities/Responsibilities:
People Management, Problem Solving, Communication
The role holder will:
Develop and validate appropriate test methodology and specifications for biopharmaceuticals for discovery, non-clinical and clinical use.
Ensure that work is performed in accordance with PD global working principles and quality system with appropriate safety (SHE). Maintain knowledge of the regulatory and compliance guidelines as related to the role
Generate, assess and report data with a clear understanding of its reliability interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated. Engage customers in development of solutions by applying a broader perspective
Prepare documentation and formal reports in accordance with current standards and where appropriate to GMP. Generate CMC documents for regulatory submissions or enquiries.
Apply technical knowledge to drug projects, improvement projects and the evaluation of new technology/processes. Collaboration with specialist scientific and/or technology networks within PD.
May supervise co-workers and contribute to their training and development by acting as coach/mentor.
Will work as a member of cross-functional teams, with a large degree of independence representing own group and area of expertise.
Minimum Requirements and Education and Experience
Functional & Business knowledge
You have:
Educational background at research level or equivalent work experience in an area relevant to biopharmaceuticals.
Experience in resolving complex analytical issues related to biopharmaceuticals or equivalent molecules. (i.e., separation and physical/chemical characterisation).
Knowledge of suitable quality standards and regulatory requirements for biopharmaceuticals.
For the full job description and to apply please go to
www.astrazeneca.comPubliceringsdatum2014-09-18Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2014-10-08
Vi tar endast emot ansökningar online
Ange följande referens när du ansöker: MOL000001ID
FöretagAstraZeneca Mölndal
AdressAstraZeneca Mölndal
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
Övriga kontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 2002097
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