Associate Director, Discovery Bioanalysis – Integrated Bioanalysis

Associate Director, Discovery Bioanalysis Integrated Bioanalysis - Gaithersburg, US

Check out the role overview below If you are confident you have got the right skills and experience, apply today.

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 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 diseases to patients with critical needs.

Scientific innovations are at the core of what we do across our industry-leading portfolio, which drives exciting opportunities and varied work.

We’re on an exciting journey to pioneer the future of healthcare!

The role

As part of the Integrated Bioanalysis (iBA) Global Team, you will demonstrate scientific bioanalytical leadership across a broad array of therapeutic modalities in a lab-based and project-facing role.

You will be responsible for the design and implementation of robust bioanalytical strategies and associated analytical methods to support the AstraZeneca pipeline.

You will also drive the advancement of scientific knowledge across our Biopharma and Oncology portfolios by contributing to project teams across modality.

Working with a dynamic team in a matrixed environment, you will need to manage stakeholder expectations, input to project strategy and delivery while being the main interface with experienced and highly skilled bioanalytical scientist colleagues or our partnered labs.

You will have the opportunity to have an immediate and lasting impact on our diverse pipeline.

The iBA group within Clinical Pharmacology and Safety Sciences (CPSS) 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 part of the Discovery Bioanalysis group, located at our research hub in Gaithersburg, where you will develop and deliver bioanalytical strategies and data to support a broad array of therapeutic modalities such as T cell engagers, Cell therapies, and complex biologics across Oncology and Biopharma.

You will be responsible for the development of the team’s capabilities with respect to analyzing pharmacokinetics, pharmacodynamic biomarkers, and immunogenicity with your strong scientific knowledge and expertise.

In this role, you will be highly visible; working across iBA and CPSS functions, alongside TA leads and cross-functional groups as well as contractor labs to ensure appropriate bioanalytical and platform strategies, scientific oversight, and delivery of our pipeline while fostering an environment of scientific knowledge exchange.

You will also work with colleagues involved in interactions with regulatory agencies and Health Authorities across a range of countries and geographies to submit regulatory documents and respond to Health Authority questions.

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.

Education / Experience required :

• PhD in immunology, molecular biology, or related studies with at least 2 years of industry experience.
• MSc in immunology, molecular biology, or related studies with at least 3 years of industry experience.
• BSc in immunology, molecular biology, or related studies with at least 5 years of industry experience.

Desirable for the role :

• A bioanalytical subject matter expert with a broad array of technical and scientific experience using a multitude of technology platforms, such as ligand-binding assays (LBA), molecular assays, and flow cytometry to assess pharmacokinetics, biodistribution, pharmacodynamic biomarkers, and immunogenicity.
• Proven experience as a scientific expert across a range of therapeutic modalities, especially antibody and cellular immunotherapies.
• Experienced as a bioanalytical lead in diverse project teams, defining, leading, and implementing robust bioanalytical strategy to advance the portfolio.
• Worked collaboratively with internal stakeholders and external contractor labs, providing solutions to challenges and mitigating risk.
• Interpretation of integrated and complicated datasets.
• In-depth knowledge of regulatory requirements and proven success in assay qualification and validation for a range of bioanalytical methods.
• Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI, and / or NDAs / BLAs and experience in regulatory authority responses across multiple geographies.
• Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment.
• Ability to develop, coach, and mentor.
• 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 ambitious world.

At AstraZeneca's Biopharmaceuticals R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases.

Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Are you ready to join a team unlocking the power of what science can do? Are you driven by your desire to understand and reveal new insights?

If your passion is science and you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be. Apply today!

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