Associate Director Integrated Bioanalysis

4 weeks ago

Cambridge, United Kingdom AstraZeneca Full time

**Associate Director Integrated Bioanalysis -Biopharma Bioanalytical Strategy Lead**

**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**

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 one of our research hubs ideally in Cambridge UK or Barcelona, where you will work alongside TA leads and stakeholders. In this role you will interact closely with scientist who are primarily lab based and you will be required to aid in experimental design. This is a highly visible role and you will be required to leverage your scientific knowledge and expertise while working with a range of stakeholder and cross functional groups. You will need to use your experience and proven track record designing, developing and delivering robust bioanalytical strategies with a specific focus on scientific oversight and delivery for our Biopharma portfolio. You will also work 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.

**Education/Experience required**:

- PhD in immunology, molecular biology or related studies with significant relevant experience

**Essential for the role**:

- Proven experience as a Subject matter Expert in regulated bioanalysis across a range of modalities PK/CK, PD and immunogenicity assessments (humoral and cellular)
- Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio.
- Worked collaboratively with stakeholders, providing solutions to challenges and mitigating risk.
- Skilled scientist able to discern the advantages and pitfalls of an range of analytical techniques such as molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass Spectrometry.
- In depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysis
- Overseen assay transfer, scientific quality and study conduct at CRO partners.
- Deep understanding of global regulatory expectations and guidance
- 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

**Desirable for the role**:

- Matrix or line management experience
- Experienced in regulated bioanalysis for other drug modalities.

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