Cell Therapy Director- Global Technical Operations

Apply your hands-on experience in Commercial/late stage manufacturing experience in validating processes cell or gene therapy readiness and nucleic acid manufacturing, formulation and/or formulation analytics in a company that follows the science. AstraZeneca's newly created position -Cell Therapy Director- Global Technical Operations would be an excellent opportunity for you!

AstraZeneca is at an exciting time of new products and launches. We get to work with innovative and scientific products on our leading-edge end to end supply chain, using the latest technologies and modern facilities.

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking.

The Cell Therapy Director- Global Technical Operations role was created as a cross-functional leadership position representing Biologics Operations on key early leadership teams with the primary responsibility for strategic planning and coordination of technical leadership and support from the Operations global technical network to key customers across the enterprise. The New Modalities team work with the Biologics Development to tackle new, unique and different biologic medicines including: Cell Therapies (pluripotent/regenerative, autologous, and Immune cell based), Nucleic Acid therapies (e.g. mRNA, saRNA), Antibody Conjugates ( ADCs, Radio Immune Conjugates), and other pipeline biologics, including Viral Therapies (Gene therapy and oncolytic).

What you will do:

• Act as early head of MS&T for new Modalities, lead Operations engagement with development technical and leadership teams, including, but not limited to: Early Product teams, New Modality Franchise teams, and multi-product business units, CMC and clinical strategy teams, CMC platform teams and Operations leadership, including External Sourcing, Global Supply and Strategy, and Biologics Leadership

• Work collaboratively in a Matrix Environment, establish and lead Operations standard work for New Modalities including: Validation strategies, Change managements strategies, including Comparability and ”Switch” Strategies, Technology transfer to internal and external assets

• Ensure technical capability builds can support product portfolio and bio enterprise strategy; align priorities of CMC technical teams and Biologics Operations, establish tech transfer and site technical business processes, in addition to a talent pipeline

• Co-ordinate partnership of GTO team with Regulatory, Quality Assurance, and CMC teams to support writing the technical content of regulatory filings and ensure flexibilities are built in to minimize impact of future changes

• For virtual sites in network, ensure that full scope of MS&T support is provided to Virtual site for tech transfer and commercial manufacturing for all products and sites (CMOs and OTLs), working with the existing GTO teams.

• Lead development of business processes and ways of working, technical strategies for new Modalities, Score-card updates, business planning and financial updates

Minimum Qualifications:

• Bachelor of Science required.

• Minimum 14 years of experience in biologics manufacturing OR a minimum of 10 years with advanced degree

• Recent hands on experience validating processes cell or gene therapy readiness, including one or all of autologous cells, progenitor/pluripotent cells, viral vector(s) and/or CRISPR/CAS9 based manufacturing

• Hands on experience validating nucleic acid manufacturing, formulation and/or formulation analytics, including plasmid DNA or mRNA manufacturing and analytical testing and QC strategies

• Experience in a Commercial/late stage manufacturing setting

• History of regulatory document authoring or regulatory technical strategy development

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

Preferred Qualifications:

• Late phase experience in nucleic acid manufacturing, formulation and/or formulation analytics

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

• Understanding and competency in DoE study design​

Why AstraZeneca

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

So, what’s next

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Find out more on Social Media:

• LinkedIn https://www.linkedin.com/company/1603/

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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.