Manufacturing Associate I

Responsibilities:
- Perform routine manufacturing tasks, including media preparation, cell culture, cell counting, formulation, centrifugation, and freezing
- Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols
- Mentor fellow team members on cGMP documentation protocols
- Plan, collect, analyze, and report on production data, maintaining comprehensive records and observations
- Author, revise, and maintain SOPs through the document change system
- Oversee inventory, material transfers, and cleanroom procedures to support efficient GMP operations
- Prepare technical summaries, protocols, and reports to fully document production activities
- Lead moderate-complexity CAPAs and assist with deviations and investigations to maintain quality assurance
- Take on special projects in manufacturing and development as required

Requirements:
- Bachelor’s degree in Biomedical Engineering, Biological Sciences, or a related field
- 1-3 years of experience in a cGMP/cGTP manufacturing environment
- Solid laboratory experience in mammalian tissue culture and expertise in aseptic techniques
- Working knowledge of regulatory standards in biopharmaceutical or tissue banking industries
- Strong organizational skills and acute attention to detail in a fast-paced setting
- Basic molecular biology and flow cytometry skills are a plus
- Ability to work schedules that may include weekends or holidays as needed