Manufacturing Specialist

USWM, LLC • Philadelphia, PA

3d • Onsite

About The Position

This role exists to provide support for the 1st shift 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.
• Minimum 1 year working with Advanced Cell Therapies withing a cGMP environment
• Ability to work flexible hours with some night and weekend availability is required. This is a start-up situation so schedules and shifts will change over time.
• 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.
• Authors or edit SOPs, batch records, training records, logbooks, validation plans and technical reports as assigned.
• Handles human blood and human blood-based product intermediates; Helps with warehouse management, critical reagents and material inventory reports.
• Work on project teams (continuous improvement initiatives)
• Inputting and uploading of manufacturing data in real time to existing database.
• Review of Batch Records and logbooks / comment resolution.
• Train new or junior employees on equipment and unit operations.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 11-50 employees