Associate Director (Integrated Bioanalysis)

Associate Director (Integrated Bioanalysis) - Gaithersburg, US

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 an Associate Director in the Regulatory Bioanalysis Team within Integrated Bioanalysis (iBA), we seek a highly skilled and scientifically driven individual with deep expertise in bioanalytical sciences for biologics. In this role, you will independently lead the development of ground breaking scientific methods for biomarker quantification, directly supporting AstraZeneca’s drug pipelines. You will use existing technologies and explore novel techniques as needed to advance our biomarker measurement capabilities.

This position is hands-on and laboratory-based, where you will lead the development and optimization of assays critical to preclinical and clinical studies. You will also play a key role in shaping the bioanalytical strategy for drug development programs in collaboration with the Bioanalytical project lead. Strong scientific leadership as well as collaboration and communication skills are essential, as you will work closely with intra- and inter-departmental teams, manage stakeholder expectations, and work with experienced bioanalytical scientists and partnered laboratories.

This is a unique opportunity to make a significant impact on AstraZeneca's diverse pipeline. The iBA group, part of Clinical Pharmacology and Safety Sciences, provides comprehensive support across all therapeutic areas, from discovery through preclinical and clinical phases, as well as life cycle management, driving pipeline delivery, innovation, and advancements that improve patients' lives 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:

• Develop, optimize, and validate bioanalytical methods for biomarker quantification using current technologies and/or exploring novel techniques/platforms as needed.

• Be required to understand the biomarker and its biology of interest and develop a method development strategy to fulfil its context of use. 

• Troubleshoot and resolve technical issues in bioanalytical method development to ensure the generation of reliable and high-quality data.

• Document experimental procedures and results in compliance with regulatory guidance, internal SOPs, and company standards.

• Review and interpret bioanalytical data, ensuring data is reported accurately and the interpretation is scientifically sound.

• Identify and address any issues affecting study quality and integrity and contribute to the preparation of technical and regulatory submission documents.

• Stay current with advancements in bioanalytical technologies to drive innovation as well as the evolution of regulatory requirements and industry best practice.

• Partner with Bioanalytical Project Leads to ensure assays are fit for their intended purpose and the data is properly interpreted.

• Collaborate with internal teams and external vendors to transfer bioanalytical methods and foster knowledge exchange.

• Provide scientific and technical input to study teams and participate in cross-functional project discussions.

• Interact regularly with stakeholders and cross functional project teams.

• Works with Senior management to develop and set vision for department activities and management of resources.

• Mentor junior scientists, promoting a culture of excellence and continuous improvement.

Education & Experience Requirements:

Education: PhD in Molecular Biology, Biochemistry or related field

Experience: PhD with 8+ years of experience in bioanalytical method development

Required Skills & Experience:

• Extensive hands-on experience in developing and validating bioanalytical methods for biomarker quantification, with proficiency in platforms for multiplexing and/or ultrasensitive detection.

• Strong problem-solving skills with a proven ability to address and resolve technical challenges in assay development.

• Excellent communication and collaboration skills, with the ability to present data and strategies clearly to both scientists and management

• Work effectively with cross-functional teams.

• Solid background in lab-based method development and validation, with experience in GxP settings.

• Strong accountability and commitment to data quality, following good laboratory and documentation practices.

• Knowledge of regulatory guidelines (e.g., GLP/GCP) and experience contributing to regulatory submissions.

• Demonstrated ability to manage multiple projects in a fast-paced environment, with strong organizational and interpersonal skills.

• Proven track record of scientific contributions, including publications and presentations.

Desired Skills & Experience:

• Experience with multiple bioanalytical technologies/platforms such as LBAs, LCMS, and cell-based assays will be desired.

• Familiarity with automation technologies and high-throughput assay development.

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!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.