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Associate Director

2 months ago

Gaithersburg, United States AstraZeneca Full time

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.

  • Foster advance technical applications to ensure data quality.

  • Demonstrate strong accountability, organizational and interpersonal skills, and apply scientific and technical experience.

  • 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 verbal and written communication skills.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what's next?

Are you ready to make an incredible impact? Join us at AstraZeneca, where your work is recognized across the enterprise, and externally too. Apply today

Date Posted

06-Sep-2024

Closing Date

24-Sep-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.PDN-9cf32523-5b3a-40a3-b181-a4e1240bbb52