Associate – Packaging Operations and Cold Chain Handling - Day Shift

Salary Range: 23 to 29 (Currency: USD) (Pay period: per-hour-wage)

Physical Demands & Work Conditions

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Must be comfortable regularly participating in video-based meetings.

Essential Duties & Key Responsibilities

• Blood Intake & Chain-of-Identity Management:
• Receive and verify incoming apheresis materials according to SOPs and regulatory requirements. 
• Perform visual inspections and documentation checks to ensure proper labeling, temperature, and packaging. 
• Maintain strict adherence to chain-of-identity and chain-of-custody procedures. 
• Cryopreservation Support: 
• Assist in the preparation and cryopreservation of intermediate and final cellular products. 
• Operate and maintain cryogenic storage equipment (e.g., controlled-rate freezers, LN2 tanks). 
• Accurately complete batch records and electronic documentation systems. 
• Drug Product Shipment: 
• Coordinate the labeling, packaging, and final release of drug product for shipment. 
• Prepare shipping materials, confirm shipping conditions (e.g., temperature control), and liaise with logistics partners. 
• Ensure real-time data entry into inventory, tracking systems and eBRs 
• Perform other duties as assigned 
• Work closely with Quality Assurance, Supply Chain, and Manufacturing teams to ensure timely and compliant operations. 
• Support deviation investigations, CAPAs, and continuous improvement initiatives as needed. 
• Maintain accurate and complete records in accordance with GMP and GDP standards. 
• Good Manufacturing Practices (GMP) Training  

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field preferred. 
• 1-3 years of experience in a GMP-regulated biotech or pharmaceutical environment preferred. 
• Strong understanding of cell therapy manufacturing processes  
• Strong attention to detail, organizational skills and document accuracy. 
• Ability to work with biological materials and cryogenic systems 
• Knowledge of regulatory compliance (FDA and GxP) a plus 
• Comfortable working in a clean room and or cold environment (Liquid Nitrogen storage) 

Travel Requirements and Work Environment

• Domestic and international travel not required 
• May involve standing for extended periods and lifting up to 25 lbs 
• Shift work, weekends, or holidays may be required depending on production needs 
• Exposure to human blood products and temperature-controlled storage areas 
• Gowning and use of Personal Protective Equipment required