Join us at AstraZeneca as an Associate Director Digital Manufacturing Systems at our cell therapy facility in Rockville, Maryland, the newest addition to our global supply network. We aim to make a direct impact on patients by delivering life-saving cell therapies. This is your chance to break new ground and leave a collective legacy! We are investing in internal capabilities across our R&D and manufacturing organizations to help us realize our ambition to discover and deliver next-generation cellular therapies.
The Associate Director is part of the Technical Operations team, managing and leading a Digital Manufacturing Systems team, overseeing the design, implementation, and maintenance of PAS-X Electronic Batch Records (EBR) and support of digital manufacturing systems (SCADA). The Digital Manufacturing Systems team is the interface between IT and Manufacturing.
What you will do:
Management and leadership of the Digital Manufacturing Systems team including:
Manage, and lead the Digital Manufacturing Systems team to support and enhance digital systems used in Manufacturing.
Performance management, talent management of direct reports
Responsible for the design, implementation/validation, and maintenance of electronic batch records (PAS-X)
Responsible for scripting of SCADA system to monitor data for process performance, trending, investigation support
Responsible for Electronic documentation system to support manufacturing
Create standards and instructions for the use of digital systems.
Recipe and user access management of manufacturing systems
Drives continuous improvements using Lean and Six Sigma principles.
Collaborate with cross-functional teams to understand manufacturing requirements and ensure alignment with system design and updates.
Staying up to date with industry trends for digital manufacturing systems
Minimum Qualifications:
Minimum BS degree required in engineering or related field.
Minimum 5 years of work experience in clinical or commercial biologics or cell therapy manufacturing under cGMP.
Minimum 3 years prior supervisory or management experience
Knowledgeable of the current Code of the Federal Regulations (especially 21 CFR Part 11) and Current Good Manufacturing Practices (cGMP's)
Strong people management skills, coaching, motivating, and building a team.
Capable of identifying areas of improvement and leading change.
Experience with working with digital manufacturing systems, data collection, analysis, and visualization
Preferred Qualifications:
Experience in autologous cell therapy manufacturing
Experience working with Electronic batch records (PAS-X)
At AstraZeneca, we are driven by innovation and our commitment to improving lives. We are a diverse, multigenerational team of experts connected across the globe. We interpret the science, connecting it with the business need to apply manufacturing excellence. 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 make a difference? Apply today and join us in our mission to deliver life-changing medicines
Date Posted
16-Sep-2024Closing 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.