Aseptic Cell Therapy Manufacturing Associate Flexible Hours

US WorldMeds; Philadelphia (Philadelphia County); On-site; USD 75,000 - 95,000; Full time

Job summary

US WorldMeds seeks a Cell Therapy Manufacturing Specialist to support gene-modified autologous T-cell production at the Philadelphia Navy Yard site. The role involves aseptic cell processing, media formulation, sampling, and recordkeeping in a cGMP environment.

Responsibilities include training staff, maintaining batch records, and contributing to continuous improvement initiatives. Flexible hours and weekend shifts may be required due to start-up dynamics; strong communication and computer

Qualifications

• Bachelor's degree in cell biology, bioengineering or medical technology related field, or equivalent experience.
• Minimum 1 year working with Advanced Cell Therapies in a cGMP environment.
• Ability to work flexible hours including some nights and weekends.
• Demonstrated GMP/GDP knowledge (21 CFR Part 210/211 & 21 CFR Part 11).
• Aseptic cleanroom experience with full gowning required.
• Excellent verbal and written communication skills.
• Proficient computer skills: Outlook, Word, Excel, PowerPoint.

Responsibilities

• Performs cell manufacturing activities in clean room attire in aseptic cGMP.
• Documents production operations in batch records and logbooks.
• Identifies deviations and communicates them to Manufacturing and QA.
• Authors or edits SOPs, batch records, and training records.
• Trains new or junior employees on equipment and unit operations.

Skills

Advanced Cell Therapies

GMP/GDP knowledge

Aseptic cleanroom

Communication skills

MS Excel proficiency

Education

Bachelor's degree in cell biology, bioengineering or medical technology related field, or equivalent experience

Tools

MS Office

Job description

US WorldMeds seeks a Cell Therapy Manufacturing Specialist to support gene-modified autologous T-cell production at the Philadelphia Navy Yard site. The role involves aseptic cell processing, media formulation, sampling, and recordkeeping in a cGMP environment.

Responsibilities include training staff, maintaining batch records, and contributing to continuous improvement initiatives. Flexible hours and weekend shifts may be required due to start-up dynamics; strong communication and computer