Associate Director Integrated Bioanalysis

2 weeks ago

Gaithersburg, United States AstraZeneca Full time

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

**Locations - Gaithersburg, MD**

**Comprehensive salary and benefits package**

**Introduction to Role**:
Are you ready to make a significant impact in the world of bioanalysis? As part of the Integrated Bioanalysis (IBA) Global Team, you will be leading the design and implementation of robust bioanalytical strategies. This role is pivotal in ensuring lab-based activities are aligned with context of use. You will be working in a matrix environment, managing aspects such as experimental design and tech transfer. This role requires close interaction with other scientific and technical staff in the lab. If you have a strong track record in regulated bioanalysis supporting therapeutic modalities across a range of therapeutic areas, this could be the perfect opportunity for you

**Accountabilities**:
In this role, you will be located at one of our research hubs ideally in Gaithersburg, MD where you will work alongside TA leads and partners. You will interact closely with scientists 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 use your scientific knowledge and expertise while working with a range of collaborators and cross functional groups. 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.

**Essential Skills/Experience**:

- PhD in immunology, molecular biology or related studies with significant relevant experience
- 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.
- Skilled scientist able to discern the advantages and pitfalls of a 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.
- Deep understanding of global regulatory expectations and guidance
- Proven publication and presentation record
- Exceptional verbal and written communication skills

**Desirable Skills/Experience**:

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

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.

**Why AstraZeneca?**
At AstraZeneca, we follow the science unlike anywhere else. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs. Our belief powers us to push the boundaries. As we improve success rates, we keep moving forward. Celebrating both successes and failures along the way. We're investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success. Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease.

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