Associate Director, Flow Cytometry Specialist

Associate Director- Flow Cytometry Specialist- 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!

The role

As part of the Cell and Gene Therapy Group in 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 use your experience and know how in Flow Cytometry to help evolve and implement strategies to assess cellular kinetics, cellular dynamics & pharmacodynamics, working as part of a team responsible for the design and implementation of robust bioanalytical strategies and associated analytical methods to support the AstraZeneca cell & gene therapy pipeline. You will also drive the advancement of scientific knowledge across our Biopharma and Oncology portfolios by contributing to project teams across various novel modalities. Working with a dynamic team in a matrixed environment you will need to manage partner expectations, input to project strategy and delivery while being the main collaborate 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 (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 located at our research hub in Gaithersburg, where you will provide scientific oversight to deliver on bioanalytical strategies across a broad array of therapeutic modalities. You will be responsible for development of the teams’ Flow Cytometry capabilities with respect to cellular kinetics, cellular dynamics & pharmacodynamics, inputting into strategy, science, and tactical operations. In this role you will be highly visible; working across iBA and CPSS functions, alongside TA leads and partners, and able to use scientific knowledge and expertise while working with a range of cross functional groups. You will need to use your experience and consistent track record designing, developing and delivering robust bioanalytical strategies and associated bioanalytical methods. You will also work with colleagues involved in interactions with regulatory agencies and Health Authorities across a range of countries and geographies to mitigate risk, 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.

The successful candidate will work closely with AstraZeneca laboratory groups within iBA and our vendor partners to ensure appropriate bioanalytical and platform strategies, scientific oversight and delivery of our pipeline while fostering an environment of scientific knowledge exchange.

Education/Experience required:

• PhD degree in immunology, molecular biology or related studies preferred; with 0-3 yrs of relevant experience

• M.Sc..required with 3-5 years of relevant experience

• BSc considered with 5+ years of experience in lieu of degree required
  

Desirable for the role:

• A bioanalytical subject matter expert with a broad array of technical and scientific experience using Flow Cytometry technology platform to assess cellular kinetics, cellular dynamics & pharmacodynamics.

• Proven experience as a scientific expert across a range of therapeutic modalities.

• Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.

• Work collaboratively with partners, providing solutions to challenges and mitigating risk.

• Skilled scientist able to discern the advantages and pitfalls of a range of analytical techniques

• In depth knowledge of concepts such of context of use of fit for purpose assay validation/ qualification in bioanalysis

• Contributed to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies.

• Interpretation of integrated and 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

• Exceptional verbal and written communication skills

Salary: Competitive

So, what’s next?

Are you already envisioning yourself joining us? Good, because we can’t wait to hear from you!

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.