Manufacturing Associate (Biopharmaceutical Manufacturing) — Day Shift (Quad 1) | cGMP Cleanroom Environment
Shift Schedule: Sunday–Wednesday, 5:00 AM–5:30 PM (times may change).
Key Responsibilities
- Set up and operate equipment for blood component production (cell culture, harvest, cryopreservation)
- Use aseptic technique (incl. tube welding, connections, transfers); aseptic qualification required
- Weigh/measure in-process materials
- Adhere to production schedule and support internal logistics
- Record production data per GDPs
- Support deviation investigations/write-ups
- Ensure on-time closure of assigned CAPAs
- Follow site safety, quality systems, and GMP requirements
- Work in cross-functional shift-based team; meet training assignments
- Develop SME/qualified trainer status within a manufacturing function
- Contribute to continuous improvement, inspection readiness, and right-first-time initiatives
Qualifications & Required/Preferred Skills
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing/lab technique
- Familiarity with cGMP and FDA-regulated standards
- Strong technical writing; basic math knowledge of cGMPs
- Proficiency in Microsoft Office
- Preferred: biology/chemistry/medical/clinical background; prior manufacturing and/or scientific/engineering experience
Education / Experience
- Bachelor’s degree
- Associate’s/Medical Technical degree + 3+ years Manufacturing Operations
- High school/GED + 2+ years Manufacturing or Operations
Working Conditions
- Specialized cleanroom/lab; ability to lift up to 25 lbs; PPE/cleanroom garments; exposure to reagents/chemicals/sanitizers/human blood components/magnets; comfort with contained human blood components.
Compensation & Benefits (as stated)
- $27.83–$33.72/hour (Summit West–NJ–US)
- Benefits include medical/pharmacy/dental/vision, wellbeing programs, and 401(k) plus disability/life insurance and other listed protections; paid time off per eligibility.