Associate Director Integrated Bioanalysis –Biopharma Bioanalytical Strategy Lead
Possible locations - Cambridge UK, Barcelona or Gothenburg
Competitive salary and excellent benefits package
Introduction to Role:
As part of the Integrated Bioanalysis (IBA) Team, you will be responsible for leading the design and implementation of robust bioanalytical strategies, including but not limited to, endpoints such as PK/CK, immunogenicity and biomarkers when required to support the AstraZeneca pipeline. You will be intimately involved in ensuring lab-based activities are aligned with context of use.
You will handle aspects such as experimental design and tech transfer and will need to foster close interaction with other scientific and technical staff in the lab. 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 bridge between 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!
Using your experience and proven track record designing, developing and delivering 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, your role will involve enhancing the IBA reputation for scientific excellence by presenting at internal and external meetings, and publishing manuscripts.
You will be located at one of our research hubs where you will work alongside TA leads and collaborators. In this role you will interact closely with scientists who are primarily lab based and you will 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 customers and cross functional groups.
The ideal candidate will have a strong track record in regulated bioanalysis supporting therapeutic modalities across a range of therapeutic areas including but not limited to Cardiovascular, Renal and Metabolism (CVRM), Respiratory and Immunology (R&I), Vaccines and Immune Therapy (V&I) and Neuroscience (NS) across a range of modalities.
- 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.
- Worked collaboratively with collaborators, providing solutions to challenges and mitigating risk.
- 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.
- In depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysis
- Supervised 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.
- 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.
Join the team unlocking the power of what science can do. 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. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.
Ready to make a difference? Apply today!
So, what’s next?
We encourage your application no later than 10th December
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.