Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
1+ years of laboratory experience within the biotech or pharma industry (cell or gene therapy a plus)
2+ years of experience in mammalian cell culture in an academic or industrial laboratory
Knowledge of basic laboratory skills (aseptic technique, pipetting, etc.) are required
Must be comfortable with performing tasks while fully gowned in a cleanroom environment.
Proficient in Manufacturing Process.
Knowledge of 21CFR Part 11, standard GxP best practices and other industry standards.
Proficient in Mammalian cell biology
Excellent verbal and written skills
Good interpersonal communication skills
Must be willing to work weekends, evenings, and holidays (as needed).
Responsibilities:
Proficient in aseptic processing including media exchanges, vessel passaging, harvest & cryopreservation of cells as required by the daily production schedule.
Ability to complete and maintain aseptic gowning qualification, aseptic process qualification, and cleaning & disinfection qualification.
Perform media and reagent preparation duties as required.
Ability to operate and maintain equipment.
Perform equipment preventative maintenance, cleaning/disinfection, and basic troubleshooting, as required.
Perform, record and report various inventory tasks (i.e. consumables, media, cryovial, etc.)
Ability to train others on support tasks, basic SOPs, equipment, and process operations.
Achieves PowerUser status on supporting electronic systems (i.e., MasterControl).
Follows, revises, executes, and authors SOPs and MBRs in accordance with cGMPs.
Ability to author and review documentation and MBR's at a high level.
Ability to author and close quality items, including quality event investigations and deviations.
Ability to initiate simple change controls and manage tasks required.
Assists with material procurement and receipt.
Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements.
Manages time well and multi-tasks to complete all assignments and responsibilities with supervisor's guidance.
Maintains a safe working environment for self and others, including work area cleanliness.
Monitors resources and enforces SOPs to ensure data integrity and compliance with industry.
Participates in process optimization and continuous improvement opportunities.