Using general application of principles supports activities to ensure GMP readiness for clinical manufacturing including equipment procurement, installation and qualification, facility qualification and technology transfer.
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
Develop Standard Operating Procedures (SOPs) for manufacturing processes.
Set up manufacturing areas and equipment, including complex automated cell processing equipment.
Follow all cleaning and gowning procedures for the facility.
Maintain appropriate inventories of material and supplies within the cleanroom areas to support manufacturing activities.
Ensure all materials and equipment are identified and available in time for manufacturing activities.
Support Process Development to align manufacturing plans with product development plans.
Ensure that all production operations are controlled and performed within cGMP regulatory guidelines.
Provide verbal and written updates to Manufacturing leadership.
Other responsibilities and projects as assigned to meet our needs.
Experience and Education
Must have a minimum of five (5) years with High School or BS/BA in relevant science or engineering discipline.
Understanding of cGMP process and knowledge of CMC regulatory framework for biologics.
Knowledge of aseptic techniques for primary human cell cultures and GMP manufacturing and supporting tech transfer and GMP clinical/commercial manufacturing operations.
Additional Requirements
Knowledge of industry practices, cell therapy manufacturing experience preferred.
Develop solutions to complex problems independently.
Refer to established precedents and policies or use original thinking.
Help determine goals of assignment.
Plan schedules and arranges own activities.
Work is reviewed upon completion for adequacy in meeting goals.
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.
