Senior Scientist Integrated Bioanalysis – Molecular specialist

Senior Scientist Integrated Bioanalysis – Molecular specialist

Introduction to Role:

Join our dynamic Cell & Gene Therapy group within Integrated Bioanalysis (iBA) Global Team. As a Senior Scientist, Molecular Specialist you will be responsible for developing assays with a specific focus on the assessment of cellular kinetics and biodistribution for our cell and gene therapy portfolio. This role is an exciting opportunity to work with a diverse pipeline and have an immediate and lasting impact. Embrace new and varied opportunities to develop and learn in an environment built on lifelong learning. This is the place to build a long-term meaningful career, working on things that have never been done before.

The ideal candidate will have extensive technical expertise in developing molecular assays on multiple analytical platforms including qPCR and ddPCR. You will be responsible for assay development, optimization, qualification, execution of high complexity bioanalytical methods. You will also contribute to the tech-transfer of methods to internal regulatory teams and/or established CRO partners and be called upon to review data to ensure assay are fit for purpose including troubleshooting and data analysis. As part of an agile, dynamic team you will have the opportunity to be exposed to other areas of bioanalysis such as biomarkers and/or immunogenicity. You will be expected to develop strong collaborations intra and inter-departments and to contribute to the development of advanced bioanalytical techniques across all aspects of AZ portfolio within Oncology and BioPharma.  Working with a dynamic team in a matrixed environment you will need to manage stakeholder expectations, input to project strategy and delivery whilst interfacing with experienced and highly skilled bioanalytical scientist colleagues or our partnered labs.

The iBA group within Clinical Pharmacology and Safety Sciences provides broad discovery, preclinical, and clinical support including life cycle management across all therapeutic areas enabling pipeline delivery, decision making, innovation and advancement to improve the lives of patients through life-changing medicines.

The iBA group within Clinical Pharmacology and Safety Sciences provides broad discovery, preclinical, and clinical support including life cycle management across all therapeutic areas enabling pipeline delivery, decision making, innovation and advancement to improve the lives of patients through life-changing medicines.

What you’ll do

You will be located at our research hub in Gaithersburg, as part of a dynamic laboratory team, where you will work alongside experienced bioanalytical scientists supporting a range of needs across our cell and gene therapy portfolio. You will be responsible for assay development, optimization, qualification, execution, and transfer of high complexity assays using state-of-the-art instrumentation to support pre-clinical and clinical studies.  Alongside the laboratory role, you will have the opportunity to impact projects as a discovery bioanalytical lead, interacting with stakeholders and cross functional project teams.

You will work closely with bioanalytical strategy leads in the development phase to ensure assays are fit for purpose and meet their intended context of use. You will use your experience and proven track record of assay and experimental design to support delivery of robust bioanalytical data.  You will also be called upon to interpret data and provide scientific insight.  As a Subject Matter Expert, you will be responsible for enhancing the iBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts.

The successful candidate will work closely with AstraZeneca laboratory groups within iBA and our vendor partners to ensure appropriate bioanalytical method are transferred to our partners while fostering an environment of scientific knowledge exchange.

Education/Experience required:

• PhD, MSC 0-3yr experience, BSc 3+ yrs experience- immunology, molecular biology or related studies with significant relevant experience

Desirable for the role:

• Proven expertise as a Subject Matter Expert in molecular assay techniques, qPCR, ddPCR, RT-qPCR, including the development of robust, state of the art assays for bioanalytical characterisation in preclinical and clinical studies.

• Experience across a range of therapeutic modalities, cell and gene therapy experience is advantageous.

• Design, execute, and troubleshoot assays to ensure they are fit for purpose.

• Contextualize and interpret complex and integrated datasets for use in key project decisions.

• Provide bioanalytical support for pre-clinical and clinical-scale non-GLP IND-enabling studies, including assay qualificatio