Director Job at AstraZeneca, Gaithersburg, MD 20878

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Job Description

Group Director Integrated Bioanalysis – ADC Discovery 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 to 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!

The role

As part of the Integrated Bioanalysis (iBA) Global Team, you will be responsible for leading the LC-MS lab capabilities at our Gaithersburg discovery lab as well as spearhead local interfaces with TA leads focused on targeted drug delivery systems such as ADC’s. The successful candidate will be a recognized leader in the field of discovery mass spectrometry applications supporting early portfolio needs. The ideal candidate will ensure that technical skills and bioanalytical methods are fit-for-purpose how the data will be used to guide rapid discovery efforts. This is an important leadership role responsible for strengthening technical capabilities and talent development to design and implement robust bioanalytical strategies including but not limited to endpoints such as PK and biomarkers when required to support the AstraZeneca pipeline. The ideal candidate will have a proven track record in drug discovery environment with a particular focus on antibody-drug conjugates and targeted protein quantitation. Working with a dynamic team in a matrixed environment you will need to interact with stakeholders, mange expectations, input to project strategy and delivery within a highly skilled bioanalytical team. You will have the opportunity to have an immediate and lasting impact to our diverse pipeline.

The Integrated Bioanalysis team 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 Gaithersburg hub where you will work alongside TA leads and stakeholders. In this a highly visible laboratory-based role working collaboratively with scientific knowledge leaders across functional groups. You will utilize your experience and proven track record to design and develop sophisticated assays to deliver robust bioanalytical data that will impact drug design and development. You will also work with a range of colleagues across several key groups influencing drug design, exposure efficacy relationships and safety and tolerability preparing for candidate selection. As a Subject Matter Expert, you will enhance the reputation of Integrated Bioanalysis for scientific excellence by presenting at internal and external meetings, and publishing manuscripts.

The successful candidate will work closely with AstraZeneca laboratory groups within Integrated Bioanalysis and our vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery of targeted protein quantitation especially for ADCs fostering an environment of scientific knowledge exchange.

Education/Experience required:

  • PhD in Analytical Chemistry, Biochemistry or related discipline with at least 10 years post-PhD experience. Must possess relevant industry experience.

  • Master’s degree in Analytical Chemistry, Biochemistry or related discipline with at least 15 years’ experience post Masters. Must possess relevant industry experience.

Essential for the role:

  • Validated experience as a subject matter expert in discovery bioanalysis for including but not limited to PK, PD and immunogenicity of ADCs and complex biotherapeutics

  • Experienced as a discovery bioanalytical lead on diverse project teams, defining, leading, and implementing robust bioanalytical strategy and methodologies

  • Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk

  • Proven track record in line management and developing talent to meet the portfolio needs

  • Skilled in development and implementation of complex bioanalytical methods with focus on hybrid LBA-LC-MS/MS and LBA-HRMS

  • Expertise in variety of mass spectrometers (QQQ and HRMS) from different vendors

  • Expertise with analytical flow and microflow separations methods

  • Deep understanding of how bioanalytical endpoints impact drug design efforts, including biotransformation of ADCs

  • Interpretation and integration of complicated datasets

  • Ability to handle multiple projects and / or tasks concurrently in a fast-paced environment

  • Ability to develop, coach and mentor

  • Background in pharmaceutical clinical trial research

  • Proven publication and presentation record

  • Outstanding verbal and written communication skills

Desirable for the role:

  • Experienced in multiple therapeutic modalities

  • Oversee assay transfer, scientific quality and study conduct at CRO partners

  • Awareness of regulatory submission needs across geographies

  • Expertise of multiple analytical methods including ligand binding assays and techniques to determine immune response

Additional information

Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines.

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