Cell Therapy Manufacturing Support Associate

Eurofins•Exton, PA

1d•Onsite

About The Position

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a place to call home, apply with us today!

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

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.
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.