Flexible Hours: Gene Therapy Manufacturing Associate I

USWM, LLC; Philadelphia (Philadelphia County); On-site; USD 42,000 - 56,000; Full time

Job summary

USWM, LLC in Philadelphia Navy Yard is seeking a Manufacturing Associate I to support manufacturing of gene-modified autologous T-cell product. The role involves cell processing, media formulation, sample handling, and assisting with manufacturing needs in aseptic cGMP environment and inventory coordination.

The ideal candidate has a relevant bachelor’s degree or equivalent experience, with at least 1 year in Advanced Cell Therapies, and flexibility for varying shifts.

Qualifications

• Bachelor’s degree in cell biology, bioengineering or medical technology related field, or equivalent experience.
• Minimum 1 year working with Advanced Cell Therapies within a cGMP environment.
• Ability to work flexible hours with some night and weekend availability.
• Demonstrated GMP/GDP knowledge (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: Outlook, Word, Excel and Power Point.

Responsibilities

• Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner.
• Authors or edit SOPs, batch records, training records, logbooks, validation plans and technical reports as assigned.
• Work on project teams (continuous improvement initiatives).
• Inputting and uploading 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.

Skills

Communication skills

GMP/GDP knowledge

cGMP environment experience

Education

Bachelor’s degree in cell biology, bioengineering or medical technology related field

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

USWM, LLC in Philadelphia Navy Yard is seeking a Manufacturing Associate I to support manufacturing of gene-modified autologous T-cell product. The role involves cell processing, media formulation, sample handling, and assisting with manufacturing needs in aseptic cGMP environment and inventory coordination.

The ideal candidate has a relevant bachelor’s degree or equivalent experience, with at least 1 year in Advanced Cell Therapies, and flexibility for varying shifts.