Manufacturing Specialist
The Specialist, Manufacturing role will ensure successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP. You will support manufacturing operational readiness and the successful technology transfer of pipeline products using knowledge of cGMP regulations.
You Will:
Use general application of principles, support 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.
Help 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.
Perform other responsibilities and project-based assignments as needed to support manufacturing operations.
You Have:
Minimum of five (5) years of experience with a High School Diploma or two (2) years of experience with a BS/BA in a 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.
The annual base salary for this position ranges from $64,221.60 to $96,332.40. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Our Benefits:
Benefits offered include:
A qualified retirement program [401(k) plan]
Paid vacation, holidays, and paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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Date Posted
03-Jun-2025Closing Date
29-Jun-2025Our 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. ]]>We’ll keep you up to date
