Scientist, Clinical Immunology and Bioanalysis
Scientist I, Clinical Immunology and Bioanalysis
Location: Cambridge, UK
How would you like to work in state-of-the-art laboratories, driving innovation to enable new drug discovery? MedImmune, worldwide biologics research and development arm of AstraZeneca, are seeking a talented Bioanalytical Scientist to focus on the development and validation of key Immunoassays.
In this primarily lab based position, within the Clinical Immunology and Bioanalysis department, you will play a pivotal role in development, validation and subsequent application of bioanalytical immunoassays for the determination of pharmacokinetics, pharmacodynamics and immunogenicity.
You will perform the activities in a timely manner, consistent with scientific requirements and conducted in compliance with GLP or GCP for labs as applicable. This is a diverse role where you'll have the opportunity to work at multiple stages of the pipeline from lead selection, preclinical stages and throughout all stages of clinical development. Your work will support a variety of therapeutic disease areas and stakeholders.
If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.
Main Duties and Responsibilities
As a Scientist within Clinical Immunology and Bioanalysis team you will take responsibility for planning, co-ordinating and undertaking the development, validation and use of bioanalytical immunoassay based assays (PK, PD/Biomarker and Immunogenicity). You will perform sample analysis (clinical and preclinical) for regulated and non-regulated studies and/or phases to specific time lines and regulatory requirements. Acting as a Study Director for method validation studies and/or Principal Investigator for regulated phases for multi-site studies and/or Analytical Project Manager for clinical studies, you will have an oversight of analysts working on the studies/phases and ensuring regulatory compliance that holds up to QA and MHRA scrutiny. The role involves working with multiple teams (toxicology, PKPD modellers, clinical project managers, biostats, data programming, QA) to ensure delivery of data and authoring of bioanalytical sections for regulatory documentation such as INDs and/or CTAs. You will be responsible for production of Non-compartmental analysis (WinNonlin) datasets to determine PK parameters.
Additionally, you will ensure that relevant equipment are maintained, validated and in good working order in accordance with prevailing regulatory standards. You will be involved in preparation of and adherence to GLP/GCP documentation e.g. SOPs, plans and reports and representation of the function at project meetings, advising and driving bioanalytical strategy. Presentation of data externally at meetings and conferences. Understanding the practices and concepts of laboratory health and safety and observing and contributing to the company's health and safety policy will be an important part of your role.
- BSc or equivalent in a Biological Science or equivalent
- Practical experience of developing, validating and performing bespoke immunoassays in a laboratory environment according to regulatory requirements, specifically PK, PD Target Engagement assays, Biomarker assays and/or Immunogenicity assays
- Practical experience of immunoassay platforms (e.g. Gyrolab, MSD, ELISA, AlphaLISA/AlphaScreen, Aushon BioSystems)
- Performed regulated sample analysis campaigns (preclinical, clinical or both) to fixed deadlines/database locks
- Proven experience as a Study Director for assay method validation studies and/or Principal Investigator for multi-site studies
- Representing the function within global project teams and a working knowledge of pharmaceutical drug develoment
- Authoring of regulatory documentation such as INDs or CTAs
- Practical experience of immunogenicity assays (including cell-based neutralising antibody assays), Biacore and automation
- Practical experience of LC-MS as long as that experience is not at the expense of any immunoassay techniques
- Experience of being audited by QA and regulatory authorities such as MHRA and/or FDA
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
MedImmune is an equal opportunity employer. MedImmune 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.
Opening date: 5th October 2017
Closing date: 4th November 2017