Manufacturing Associate I
About The Position
The Manufacturing Associate I supports the manufacture of gene-modified autologous T-cell products at a manufacturing site in the Philadelphia Navy Yard. The role performs cell processing, media formulation, product sampling, and other manufacturing activities according to the employee’s training and experience. Work is primarily conducted in Grade B and Grade C aseptic manufacturing environments, with possible support for process development runs in the Manufacturing Science and Technology laboratory. The associate performs manufacturing activities in cleanroom attire using aseptic cGMP practices and serves as a subject matter expert on unit operations. The role documents production in batch records and logbooks, identifies and communicates manufacturing issues, prepares or edits controlled documents, handles human blood and blood-based product intermediates, supports inventory and warehouse activities, contributes to continuous improvement projects, enters manufacturing data, reviews records, and trains new or junior employees.
Requirements
- Bachelor’s degree in cell biology, bioengineering, medical technology, or a related field, or equivalent experience.
- At least 1 year of experience working with advanced cell therapies in a cGMP environment.
- Ability to work flexible hours, including some night and weekend availability.
- Demonstrated strong understanding of GMP/GDP, including 21 CFR Part 210/211 and 21 CFR 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, including Microsoft Outlook, Word, Excel, and PowerPoint.
Responsibilities
- Perform cell manufacturing activities in cleanroom attire using aseptic cGMP practices.
- Serve as a subject matter expert on unit operations.
- Document production operations accurately and promptly in batch records and logbooks.
- Identify manufacturing deviations and atypical results and communicate them promptly to Manufacturing Management and the Quality team.
- Author or edit SOPs, batch records, training records, logbooks, validation plans, and technical reports as assigned.
- Handle human blood and human blood-based product intermediates.
- Support warehouse management and prepare critical reagent and material inventory reports.
- Participate in project teams and continuous improvement initiatives.
- Enter and upload manufacturing data in real time to existing databases.
- Review batch records and logbooks and resolve comments.
- Train new or junior employees on equipment and unit operations.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
