Cell Therapy Operations Manager - Clinical Manufacturing
AstraZeneca

Job Title:
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Cell Therapy Operations Manager - Clinical Manufacturing
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Introduction to role:
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Are you ready to make a significant impact in the world of science? AstraZeneca is seeking a Cell Therapy Operations Manager to join our Clinical Manufacturing Cell Therapy Team. This is an exciting opportunity to be part of a team that is launching our first wave of cell therapy clinical trials. As the leader of the Manufacturing Transfer and Integration team, you will play a crucial role in the cGMP operation of our new cell therapy clinical manufacturing facility. Are you ready to take on this challenge?
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Accountabilities:
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In this role, you will manage compliance activities for the cell therapy manufacturing process and supply chain. You will collaborate with site personnel to provide guidance and problem solve for manufacturing-related deviations, investigations, OOS, batch documentation, environmental excursions, shipping and logistical issues. You will author investigations, change controls, CAPAs, SOPs, batch records, training records and ensure accurate timely review and approval. You will also create and maintain manufacturing & compliance metrics, lead continuous improvement initiatives, author risk assessments, new product introductions, and data integrity assessments. Your role will also involve performing gap assessments, identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
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Essential Skills/Experience:
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• BS in biology, bioengineering or related science / biotechnology field.
• 4+ years of cGMP biopharmaceutical production setting with a focus in biologics, biotechnology, quality, and/or cell therapy manufacturing.
• Experience with Quality Systems, Quality Risk Management & Lean Manufacturing methodologies.
• Experience designing and implementing business processes.
• Attention to detail and a high level of organizational & time management skills.
• Ability to respond with a high degree of urgency to departmental and cross-functional needs and requests.
• Ability to effectively multi-task with a focus on execution and delivery.
• Proactively determine department needs and communicate these to supporting functions.
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Desirable Skills/Experience:
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• Relationship building, cross-functional working, interpersonal skills.
• Project Management experience.
• Cell therapy experience.
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At AstraZeneca, we are driven by the desire to make a bigger impact on patients. Our strong connection to the patient is what drives us every day. We are united behind one mission: finding the best solution to put our patients first. With constant new products and launches, there's never been a better time to join AstraZeneca's Supply Chain team. Here, you can shape our future with a big contribution to life-changing medicines.

Are you ready to join a diverse, multigenerational team of experts connected across the globe? Are you comfortable with change and have a sharp focus on finding solutions? If so, apply today and let's push the boundaries of Supply Chain together!

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.