Cell Therapy Manufacturing Support Associate

Job 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.

• 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 Power User status on supporting electronic systems (i.e. Master Control).
• Follows, revises, executes, and authors SOPs and MBRs in accordance with cGMPs.
• Ability to open and review documentation and M ’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.

• 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 21
  
  CFR 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).

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

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.

• 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.