Director Integrated Bioanalysis - Cell and Gene Therapy
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige Are you ready to make a meaningful impact on patients' lives? We are looking for a scientific leader to join the Cell and Gene Therapy Group within the Integrated Bioanalysis (iBA) Global Team. This is an opportunity for you to demonstrate scientific bioanalytical leadership across a broad array of cell and gene therapy modalities including Cell therapies, Gene therapies and Therapeutic Genome Editing and to have an immediate and lasting impact to our diverse pipeline.
What you will do
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.
In this role, you will be located at our research hub in Gothenburg Sweden where you will provide scientific oversight and direction to deliver on bioanalytical strategies with a specific focus on our cell and gene therapy portfolio. You will be responsible for matrix management and development of the teams' capabilities, inputting into strategy, science, and tactical operations. 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 Director in Integrated Bioanalysis you will use your experience and know-how across a range of molecular and cellular techniques to help evolve strategies to assess cellular kinetics (CK), biodistribution, immunogenicity, immune response, and biomarkers, working as part of a team responsible for the design and implementation of robust bioanalytical strategies to support the AstraZeneca pipeline. You will also drive the advancement of scientific knowledge across our Biopharma and Oncology portfolios by contributing to project teams across modality.
Essential for the role
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PhD in immunology, molecular biology or related studies with significant relevant experience
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Experience as a proven scientific leader with a broad array of technical and scientific experience using a multitude of molecular and cellular technologies
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Proven experience as a Subject matter Expert in bioanalysis across a range of modalities, including cell and/or gene therapy
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Experienced as a bioanalytical lead in diverse project teams, defining, leading and implementing robust bioanalytical strategy to advance the portfolio
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Highly skilled in understanding 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
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Proven publication and presentation record
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Exceptional verbal and written communication skills
Highly desirable for the role
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Matrix management experience, resource planning and prioritisation
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Experience working collaboratively with stakeholders, providing solutions to challenges and mitigating risk
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In depth knowledge of concepts such of context of use of fit for purpose assay validation/ qualification in bioanalysis
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Previous experience contributing to regulatory submission documentation such as INDs, CTAs, IBs, ISI and/or NDAs/BLAs and experience in regulatory authority responses across multiple geographies
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Ability to interpret integrated and complicated datasets
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Ability to handle multiple projects and/or tasks concurrently in a fast-paced environment
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Ability to develop, coach and mentor
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Background in pharmaceutical clinical trial research
Why AstraZeneca?
At AstraZeneca, we follow the science to explore and innovate. 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 by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are driven by our shared belief in what science can do - a belief in its potential to redefine what's possible.
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.
So, what's next? If this sounds like your next challenge - welcome to join us at AstraZeneca!
Please include a CV and cover letter highlighting your previous experience of importance for this role. We welcome your application no later than the February 29th, 2024.
Additional information
Our Gothenburg site:
https://www.astrazeneca.com/our-science/gothenburg.html Life in Gothenburg:
https://www.movetogothenburg.com/Make a move to Global Gothenburg:
https://www.youtube.com/watch?v=c-Iqbb4aw38About BioPharmaceuticals R&D:
https://www.astrazeneca.com/r-d.html Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2024-02-24
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-192071".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
karin.tomin@astrazeneca.com Jobbnummer 8470511
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