Description

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.
• Supervise a team including task assignments and performance management

Qualifications

Education:

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

Experience:

• 3+ years of experience in a cGMP setting
• Hands on experience with cell therapy manufacturing and mammalian cell culture
• Experience in a leadership role
• 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).

Additional Info

What to Expect in the Hiring Process: 

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader

Additional Details: 

This is a full-time, onsite position based on a first-shift schedule (Monday through Friday, 8:00am to 5:00pm), with overtime required as needed. Candidates located within a commutable distance to Exton, PA are strongly encouraged to apply. 

Excellent full-time benefits include:

• comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Ready to take the next step in your career? Apply today and join a team that’s making a difference in science every day.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Company Description

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!