Associate Director, Analytical, Cell Therapy Global MS&T at AstraZeneca in Gaithersburg, Maryland

Posted in Other 13 days ago.





Job Description:

Are you ready to redefine the future of medicine? We are looking for an Associate Director to join our Cell Therapy Operations team. This cross-functional leadership role is pivotal in defining Analytical Strategies and technologies for AstraZeneca's Cell Therapy Operations. You will represent the Cell Therapy function on key leadership teams, setting guidelines and strategies for the global Cell Therapy analytical network. This is your chance to learn more working at the cutting edge and embrace constant challenges that stimulate intellectual growth!



What you will do:



  • As an analytical lead for global MS&T, you will spearhead Operations engagement with development technical and leadership teams setting guidelines and strategy for the global Cell Therapy analytical network to include: Method qualification, validation strategies, and change management strategies, including comparability and tech transfer strategies.



  • Lead Operations standard work for new modalities, establishing and leading a technical network of key influencers and decision-makers, and coordinating partnerships with Regulatory, Quality Assurance, and CMC teams.


  • Establish tech transfer and site technical business processes for network sites and a talent pipeline.


  • Authoring and reviewing assay technology transfer to internal and external assets


  • Reference standard and Stability strategy establishment





Minimum Qualifications:



  • Bachelor of Science


  • Minimum seven (7) years of experience in biologics manufacturing


  • Recent hands-on experience validating and tech-transferring analytical methods for Autologous and/or Allogeneic cell therapy manufacturing


  • Hands-on experience qualifying and/or validating analytical methods for Cell Therapy and retroviral manufacturing


  • Demonstrated GMP experience with three or more of the following: Flow Cytometry, Rapid Microbial testing, ddPCR, LM-PCR, Next Gen Sequencing, Cytokine Detections, polydispersity assays, ELISAs


  • Experience in a Commercial/late-stage manufacturing setting


  • Proven history of regulatory document authoring or regulatory technical strategy development


  • The ability to co-create and collaborate in complex and agile environments





Preferred Qualifications:



  • Experience in nucleic acid manufacturing, and formulation, including plasmid DNA or mRNA manufacturing and analytical testing


  • Experience in viral vector testing and manufacturing, including method validation and tech transfer


  • Proficiency with PowerBI, PowerAutomate, and Microsoft Office suite of tools


  • Understanding and competency in DoE study design




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 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 are driven by innovation and our commitment to deliver life-changing medicines. We are at an exciting time of new products and launches. Our Supply Chain team is constantly striving for better, pushing the boundaries of product process management through careful monitoring of risks and decision-making. We foster an encouraging, positive environment where ideas are welcomed and rewarded. If you want to make a big impact, this is the place for you. Our contribution to life-changing medicines is why people have been here for decades. We do it for the patients.


Ready to redefine the future of medicine? Apply now and join us in our mission to deliver life-changing medicines!


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.


AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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