Manufacturing Associate - 2nd Shift
$28,000–$30,000 year
On-site · Philadelphia, Pennsylvania, United States
Job Summary
Manufacturing Associate role in gene-modified autologous T-cell product manufacturing at our site in the Philadelphia Navy Yard. The Specialist will perform cell processing activities, media formulation, product sampling, and other manufacturing needs in a Grade B/C aseptic, cGMP environment, with potential support for process development runs in the Manufacturing Science and Technology lab. Responsibilities include performing cell manufacturing tasks in clean room attire, documenting production operations in batch records and logbooks, identifying deviations and communicating with Manufacturing Management and Quality, supporting project teams and continuous improvement initiatives, and inputting manufacturing data into the existing database. Requires a Bachelor’s degree in a related field (or equivalent experience), knowledge of GMP/GDP, ability to stand for extended periods and lift up to 20 pounds, aseptic gowning experience, strong verbal/written communication, and proficiency with Microsoft Office tools. Work environment is described as typically quiet with standard manufacturing-related physical demands and equal opportunity employment.
Required Qualifications
- 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.
- Computer literacy is required including Microsoft Outlook, Word, Excel and Power Point.
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