Associate Director
2 weeks ago
**Associate Director (Integrated Bioanalysis)**
**Bold Disruptors. Push the boundaries of science. Fearlessly break new ground.**
Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We’re looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the while learning and developing core skills and experiences.
**What we do**
We are a global, science-led Biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.
**Why we love it**
The future is bright at AstraZeneca as we bring ground-breaking therapies for complex disease to patients with critical needs. Scientific innovations are at the core of what we do across our industry leading portfolio which drive exciting opportunities and varied work. We’re on an exciting journey to pioneer the future of healthcare
**About the role**
As part of Regulatory Bioanalysis Team in Integrated Bioanalysis (iBA), you will lead to develop various PCR-based bioanalytical capabilities for quantification of new modality therapeutics such as cell and gene therapy (CGT) products in preclinical and clinical studies across AZ portfolios in both Oncology and Biopharma. You will lead method development, troubleshooting and validation of PCR- based assays such as qPCR, digital PCR (dPCR), NGS, branch DNA (b-DNA) and hybridization ELISA to support GxP bioanalysis of oligonucleotides, DNA and RNA in blood, urine, tissues and other matrices for biodistribution or shedding. You will also be responsible for the tech-transfer of methods to established CRO partners and be called upon to review data to ensure assays are fit for purpose including troubleshooting and data analysis. You will also contribute to the bioanalytical strategy for drug development programs by collaborating with the Bioanalytical Strategy Lead (BSL). You will be expected to develop strong collaborations both intradepartmentally and interdepartmentally. You will be working with a dynamic team in a matrixed environment and will need to manage stakeholder expectations whilst working with experienced and highly skilled bioanalytical scientist colleagues or our partnered labs. You will have the opportunity to have an immediate and lasting impact to our diverse pipeline.
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, MD as part of a dynamic laboratory team, where you will work alongside experienced bioanalytical scientists supporting a range of needs across multiple modalities and portfolios.
In this role you will:
- Work closely with bioanalytical strategy leads to ensure assays are fit for purpose and meet their intended context of use for regulatory submission.
- Use your experience of assay and experimental design to support delivery of robust bioanalytical data.
- Interpret data and provide scientific insight.
- Enhance the iBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts.
- Work closely with AstraZeneca laboratory groups within iBA and our vendor partners to ensure appropriate bioanalytical methods are transferred to our partners while fostering an environment of scientific knowledge exchange.
- Interact regularly with stakeholders and cross functional project teams.
**Education & Experience Requirements**:
- Education: _PhD in Molecular Biology, Biochemistry or related field
- Experience: _PhD and 5+ years of relevant industry experience
**Required Skills & Experience**:
- Proven extensive laboratory experience in molecular assays and with various PCR-based bioanalytical platforms, including PCR, dPCR, NGS and b-DNA assays.
- Proven expertise includes the development and validation of robust molecular assays for bioanalytical characterisation of DNA, RNA or oligonucleotides in blood, urine, tissues and other matrices for biodistribution or shedding in preclinical and clinical studies.
- Design, execute, and troubleshoot assays to ensure they are fit for purpose, including regulatory submission.
- Contextualize and interpret complex and integrated datasets for use in key project decisions.
- Collaborate effectively to ensure productive interactions with all stakeholder groups.
- Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment.
- Follow good laboratory practice and good documentation practice as part of the requirements in GxP setting.
- Present data/strategy to scientists and management.
- Proven publication and presentation record.
- Exceptional ve
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