Under the supervision of the Technical Director of the cGMP Core this position requires the candidate to
collaborate within a team atmosphere that manufactures clinical grade vaccine products in the cGMP
Clinical Trial Manufacturing Facility.This candidate will also work independently and be assigned back up duties to support the maintenance of the facility operations.
Take biweekly particle counts in the Production Areas and prepare report, take environmental monitoring samples monthly in production areas (with Rodac Plates)
Processes supply orders on Buysite and through pharmacy, processes inventory â“ obtains certificates (Certificate of Analysis, Certificate of Sterility, Certificate of Conformance, etc.) for all items
Stock Facility and supporting areas with supplies and gowns
Maintain inventory levels for facility, vaccine preparations, cell therapy and islet preparations
Perform Endotoxin assays as need for Cell Therapy Process
Schedule and prepares microbiology lab forms in 4Medica
Deliver sterility and gram stain samples to Microbiology and obtain results through 4Medica and/or directly with Micro Lab personnel
Prepare kits of supplies used in manufacturing for all campaigns
Perform room change-over in facility after campaigns with specialized cleaning to maintain GMP fashion
Process gowns to Aramark for sterilizing/cleaning and maintains inventory levels
Assist with facility repairs/maintenance
Transport prepared vaccines/cell therapy products to the clinic or pharmacy, test and check eye wash station, change gas tanks and maintain chemical inventory for EH&S
Ability to demonstrate excellent interpersonal and communication skills required
Ability to gown and work in an aseptic/clean room environment.
Excellent verbal and written communication skills
Capacity to exhibit organizational skills required
Ability to work in a collaborative team environment
Strong emphasis on documentation according to FDA regulations
Execute and lead operation to comply with all written procedures, to include Batch Records and SOPs
Education and Experience:
Associateâ™s degree required; in a scientific field preferred
Experience working in a laboratory environment
Experience with laboratory skills and techniques
Advanced skills with Microsoft Office Suite
Technical Knowledge or Skills:
Capacity to handle multiple tasks and competing demands under tight time-frames
Ability to work under pressure, manage competing deadlines and priorities in a fast-paced environment
Ability to understand and carry out instructions and solve problems in complex situations
Ability to read and write documents including protocol and SOPâ™s
Ability to independently learn new techniques
Ability to interact with all levels of staff in a professional manner while respecting confidentiality
Excellent customer/staff interpersonal skills
Reference Contact Information
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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Internal Number: JR01705
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