Cell Therapy Operations Manager - Clinical Manufacturing

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!

Date Posted

24-Jul-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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