Cell Specialist I/II

Role Summary

The Cell Specialist I/II will participate in and lead the manufacture of HEP and HDF cell banks under direct supervision, performing tissue dissociation, spinner preparation, seeding, maintenance, and harvest of cells in a Class 10,000 clean room to support production. Activities will include production/expansion of cell banks, creation of test cells, senescence of Master Cell Banks, and production of range finders and G100 range finders, for a smooth translation into production. This position requires a high level of technical expertise in Cell Banking and Cell Culture, thereby providing support to ongoing manufacturing operations. Schedule is Monday–Friday, 7:30am–4:00pm, with weekend work/coverage as needed.

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 the team and transfer to ensure that documentation is complete and in compliance
• Harmonization with QC and Cell Culture for Cell Bank testing
• Responsible for the review/transfer of completed batch records to Quality Assurance in a timely manner
• Proficiently operate equipment according to designed procedures
• Maintain required records & adherence to established guidelines for quality control procedures, cGMP and safety
• Assist in maintaining databases for trending and analyzing cell culture technical data
• Provide technical and operational support and problem solving capabilities, as needed
• Coordinate the implementation of corrective measures to remedy deficiencies cited in audits of the manufacturing environment
• Proficiently function within a Class 100,000 and/or Class 10,000 clean room environment, ensuring personal and product safety
• Cell culture of mammalian cell banks using cell culture methods that may include T-flasks, cell factories, and spinner flasks, and cryopreservation of cell banks
• Responsible for ensuring all appropriate manufacturing documents are current and updated as required and that documentation is consistently produced with a high level of accuracy and clarity
• Proven technical and scientific proficiency
• Ability to communicate effectively with other departments
• Performs additional duties as assigned

Qualifications

• Experience in aseptic technique and clean room protocols
• High degree of manufacturing competence with a strong understanding of quality control and quality assurance concepts and the interrelation with cGMP manufacture of cellular product
• Knowledge and experience with equipment operation (e.g. incubators, controlled rate freezers, centrifuges, biosafety cabinets)
• Compliance to Standard Operating Procedures to ensure that the cell banking and tissue processing suites are in compliance and operational at all times
• Proven organizational and documentation skills
• Problem solving abilities
• Excellent communication skills
• Demonstrated leadership ability
• Cell counting on a hemocytometer
• Basic computer skills with a working knowledge of Microsoft Word and Excel
• Ability to work independently as well as in a team environment
• Manual dexterity
• Ability to work in a clean-room environment for extended periods

Education

• Associate’s Degree or Bachelor’s Degree in the biological sciences with 3+ years of experience, or 5-7 years of experience in biotechnology or related field

Additional Requirements

• Environmental Working Conditions: Ability to work in a cleanroom environment for extended periods
• Physical Requirements: Must be able to be gowned in a clean room for extended periods; Repeating motions that may include the wrists, hands and/or fingers; Approximately 6.5 hours per day standing; Occasional lifting of objects up to 25 lbs; Medium work; Can be exposed to cold temperatures (cold rooms and walk-in freezers); Occasionally around loud noises