Cell Specialist I/II

Role Summary

Cell Specialist I/II — Perform and manage all tasks required to produce cells, including tissue dissociation, spinner preparation, seeding, maintenance and harvest of cells in a class 10,000 clean room environment. Participate and lead the manufacture of HEP & HDF cell banks under supervision, supporting ongoing manufacturing operations in cell banking and cell culture.

Responsibilities

• Dissociation of tissue and manufacture cell banks according to established procedures
• Maintenance of cell bank inventory in compliance with AATB, FDA, state and local regulations
• Adherence to all protocols, policies, regulatory requirements, cGMPs, and safety guidelines
• Conduct batch record reviews with team and transfer to ensure documentation is complete and compliant
• Harmonization with QC and Cell Culture for Cell Bank testing
• Review/transfer of completed batch records to Quality Assurance in a timely manner
• Operate equipment according to designed procedures
• Maintain records and adherence to quality control, cGMP and safety guidelines
• Assist in maintaining databases for trending and analyzing cell culture data
• Provide technical and operational support and problem-solving capabilities
• Coordinate corrective measures to remedy deficiencies cited in audits
• Function within Class 100,000 and/or Class 10,000 clean room environments ensuring safety
• Cell culture of mammalian cell banks using various culture methods and cryopreservation
• Ensure manufacturing documents are current and accurately maintained
• Communicate effectively with other departments
• Perform additional duties as assigned

Qualifications

• Associate‚Äôs or Bachelor‚Äôs Degree in biological sciences with 3+ years of experience, or 5-7 years in biotechnology or related field
• Experience in aseptic technique and controlled clean room protocols
• Strong understanding of quality control/quality assurance and cGMP manufacturing of cellular products
• Knowledge of equipment operation (incubators, controlled rate freezers, centrifuges, biosafety cabinets)
• Compliance with Standard Operating Procedures to maintain compliant cell banking and tissue processing suites
• Strong organizational and documentation skills
• Problem-solving abilities and excellent communication
• Demonstrated leadership ability
• Cell counting on a hemocytometer
• Basic computer skills (Word, Excel)
• Ability to work independently and in a team
• Manual dexterity and ability to work in a clean-room environment for extended periods

Skills

• Cell banking and cell culture techniques
• Documentation and batch record management
• Regulatory compliance and cGMP awareness
• Equipment operation and maintenance
• Collaboration across departments

Education

• Associate‚Äôs Degree or Bachelor‚Äôs Degree in biological sciences (required as per qualifications)

Additional Requirements

• Ability to work weekend coverage when necessary
• Physical ability to stand for extended periods and lift up to 25 lbs occasionally