• United Kingdom, Uk

Job Description:

Do you feel passionate about the possibilities of science to change lives

Here at AstraZeneca, youll have the opportunity to make a difference in peoples lives every single day As one of the worlds premier biotechnology companies, our mission is centred on delivering life-changing products that advance world health, and help fight and cure disease AstraZeneca has a dynamic environment that cultivates collaboration and innovation We attract top minds, and we champion and build top talent

Precision Medicine within AstraZeneca focuses on matching medicines to those patients who will benefit from them most and delivers companion or complementary diagnostic assays that align with the drug development process and enable personalised healthcare approaches within our clinical portfolio

If successful youd provide scientific and regulatory molecular diagnostic expertise and delivery to drug project teams following a diagnostics approach Specifically, youd be 1 accountable for the delivery of work packages involving the development of diagnostics as agreed with project leaders 2 Accountable for delivering diagnostic science to enable diagnostic launch 3 Accountable for scientific and regulatory aspects of diagnostic test establishment in testing laboratories, quality control for the delivery to clinical studies and delivery of data packages to enable regulatory approvals including studies to support market adoption and life cycle management You would ensure that all activities are delivered demonstrating behaviours and values aligned to AstraZeneca Code of Conduct and supporting policies, standards and procedures, including compliant management of Budget, Safety, Health and Environment

A typical day in the role would include;

Leading/supporting the delivery of diagnostic testing to clinical studies as agreed with project leaders including diagnostic test establishment in partner laboratories, monitor diagnostic test data for quality control, provide scientific troubleshooting when necessary and preparation of study reports with presentation at appropriate meetings
Leading/supporting the delivery of diagnostic data work packages to enable regulatory submission and approval inclusive of studies to enable market adoption and life cycle management
Managing projects across internal and external partners in a global multi-disciplinary environment, applying scientific, technical and operational expertise Identify opportunities, propose solutions and work across boundaries in the scientific area(s) of expertise that will enable drug development projects and diagnostics labeling
Building and maintaining a knowledge of current and emerging diagnostic assay technologies in area of expertise
Driving continuous improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, adding value to projects and delivering better medicines to patients

Being accountable for the time and quality of agreed deliverables
Providing updates on the progress, risks and opportunities of the agreed deliverables to the appropriate governance bodies for review, challenge and issue resolution
Taking on small supervisory or skills transfer / training roles

Monitoring and ensuring compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance

Essential skills and experience

Scientist BA / Masters; Senior Scientist Masters / PhD or equivalent experience in a relevant subject
Broad knowledge of genomic technologies including Next Generation Sequencing (NGS)
Excellent knowledge of scientific literature with deep understanding in diagnostic related area demonstrated through publications in peer reviewed journals
Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation)
Experience of molecular test quality control, test data monitoring and troubleshooting
Experience of effectively working across internal and external boundaries
Ability to communicate with stakeholders for study updates, testing progress through oral presentations and progress reports
Ability to identify risks and escalate appropriately
Good interpersonal skills and ability to act as an ambassador for Precision Medicine internally and externally

Desirable skills and experience

An understanding of drug and companion diagnostic assay co-development and commercialisation and experience working in early and late phase projects
Demonstrable experience of analytical diagnostic assay validation and use in a clinical testing setting
Experience of delivery and use of data for diagnostic projects for regulatory submissions
Experience of working with diagnostic partners to drive timely and successful outcomes
Operational experience of clinical trial set up, documentation and monitoring
Experience of leading projects within a diagnostic or drug development organisation
Understanding of related areas eg drug-diagnostic co-development, partnering and commercialisation

Competitive remuneration and company benefits apply

AstraZeneca is an equal opportunity employer AstraZeneca will consider all qualified applications for employment without discrimination on grounds of disability, gender or gender 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

Scientist / Senior Scientist - Molecular Diagnostics

Scientific

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Engg. project Mgmt./site Engg./Civil Engg.
Role : Civil
Salary : As per Industry Standards
Deadline : 20th Feb 2020

Key Skills:

Company Profile:

Company
ASTRAZENECA PHARMA INDIA LTDarfix

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