Scientist II

Eurofins•Exton, PA

1d•Onsite

About The Position

General Responsibilities: 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. 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 maintains 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 open and review documentation and MBR’s at a high level. Ability to author and close quality items. 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. Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements. 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.

Requirements

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 maintains 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 open and review documentation and MBR’s at a high level.
Ability to author and close quality items.
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.
Maintains orderly and timely records of samples and data, in accordance with company policy and legal requirements.
Use of basic Microsoft applications efficiently.
Contribute to SOP/BR generation and revision, quality investigations, Corrective/Preventative Action initiatives, and Change Control procedures.