Job Description

A late-stage, gene therapy company headquartered in Exton, Pennsylvania is looking to hire Cell Manufacturing Associate II to their team. In this role you will be responsible for performing a variety of tasks in support of the daily production of sterile cell therapy products. Tasks are predominately performed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.

• Day/Shift: Monday-Friday, 8:00AM-4:30PM

Must have at least 6 months of experience.

• Experience: Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
• 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.

• Computer Skills: Use of basic Microsoft applications efficiently.
• Contribute to SOP/BR generation and revision, quality investigations, Corrective/Preventative Action initiatives, and Change Control procedures.

• Physical Demands:
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit, use hands and fingers to handle equipment or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

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