Cell Therapy Manufacturing Support

Eurofins USA PSS Insourcing Solutions•Exton, PA

7h•Onsite

About The Position

Responsible for performing a variety of tasks in support of the daily production of sterile cell therapy products. Tasks are predominantly performed within a cleanroom environment under current Good Manufacturing Practices (cGMP) conditions.

Requirements

Minimum Bachelor of Science degree in a scientific discipline (or equivalent industry experience)
1 year 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 an aseptic cleanroom environment.
Knowledge of 21CFR Part 11, standard GxP best practices and other industry standards.
Excellent verbal and written skills.
Good interpersonal communication skills.
Must be willing to work weekends, evenings, and holidays (as needed).

Nice To Haves

Mammalian cell biology experience is considered a plus.

Responsibilities

Proficient in aseptic technique concepts.
Ability to complete and maintain aseptic gowning qualification, aseptic process qualification, and cleaning & disinfection qualification.
Perform aseptic processing, including media exchanges, vessel passaging, harvest & cryopreservation of cells as required by the daily production schedule.
Perform media and reagent preparation duties as required.
Ability to operate and maintain equipment.
Perform equipment preventative maintenance and cleaning/disinfection as required.
Basic User trained on electronic support systems (i.e. BMRAM, MasterControl, etc.)
Perform, record, and report various inventory tasks (i.e., consumables, media, cryovials, etc.)
Follows, revises, and executes SOPs and WBRs in accordance with cGMPs.
Collects and records scientific and process data per good documentation practices (GDPs).
Participates in quality event investigations by providing accurate information.
Assists with the receipt and organization of materials.
Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements.
Manages time well and multitasks to complete all assignments and responsibilities with the 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.
Contribute to SOP/BR generation and revision, quality investigations, Corrective/Preventive Action initiatives, and Change Control procedures.