Manufacturing Associate - 1st Shift

USWM, LLC • Philadelphia, PA

2d • $28 - $30 • Onsite

About The Position

This role exists to provide support for the manufacturing of gene modified autologous T-cell product at our manufacturing site in the Philadelphia Navy Yard. The Specialist will perform cell processing activities, media formulation, product sampling, and other manufacturing needs as necessary, commensurate with the level of training and experience of employee. Work is primarily in Grade B and Grade C aseptic manufacturing environment but may also include support of process development runs in the Manufacturing Science and Technology laboratory.

Requirements

• Bachelor’s degree in a cell biology, bioengineering or medical technology related field, or equivalent experience is required.
• Demonstrated strong understanding of GMP/GDP (21 CFR Part 210/211 & 21CFR Part 11)
• Ability to stand for multiple hours and lift 20 pounds.
• Experience working in an aseptic cleanroom with full aseptic gowning.
• Excellent verbal and written communication skills are required.
• Computer literacy is required including Microsoft Outlook, Word, Excel and Power Point.

Responsibilities

• Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner. SME on unit operations.
• Documents production operations in corresponding batch records and logbooks per established procedures ensuring accuracy and timely completion.
• Identifies real-time manufacturing issues (deviations and atypical results) and communicates them to Manufacturing Management and the Quality team in a timely manner.
• Inputting and uploading of manufacturing data in real time to existing database.
• Review of Batch Records and logbooks / comment resolutions.
• Work on project teams (continuous improvement initiatives)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level