Cell Therapy Manufacturing Specialist

Eurofins•Exton, PA

15h•Onsite

About The Position

The Cell Therapy Manufacturing Specialist is responsible for executing critical manufacturing operations to support the daily production of sterile, clinical‑grade cell therapy products. This role operates predominantly within a cleanroom environment under current Good Manufacturing Practices (cGMP) and requires strong aseptic technique, attention to detail, and commitment to quality.

Requirements

Bachelor’s degree in a scientific discipline or equivalent direct industry experience.
2+ years of industry experience in mammalian cell culture within a GMP-regulated biopharmaceutical, cell therapy, or biotechnology manufacturing environment.
Demonstrated proficiency in aseptic technique and common laboratory skills (pipetting, cell handling, media preparation) gained through real-world manufacturing or industrial lab experience.
Strong understanding of mammalian cell biology and its application to cell therapy production environments.
Comfort working fully gowned in a cleanroom environment, with direct experience in classified cleanroom operations.
Familiarity with 21 CFR Part 11, GxP expectations, and industry regulatory standards for manufacturing.
Excellent verbal and written communication skills.
Strong interpersonal skills; able to work effectively in a team-oriented, production-focused setting.
Willingness to work evenings, weekends, and holidays as manufacturing demands require.

Responsibilities

Perform advanced aseptic processing activities, including media exchanges, vessel passaging, harvest, and cryopreservation of mammalian cells according to the production schedule.
Complete and maintain qualifications in aseptic gowning, aseptic process execution, and cleaning/disinfection.
Prepare media, buffers, and reagents as needed to support manufacturing activities.
Operate, maintain, and perform basic troubleshooting on production equipment.
Conduct equipment cleaning, disinfection, and preventative maintenance tasks in accordance with SOPs.
Execute, review, and contribute to the revision and authorship of SOPs and Master Batch Records (MBRs) under cGMP guidelines.
Open, investigate, and close quality records including deviations, CAPAs, and change controls.
Initiate and support simple change controls; complete associated tasks in a timely manner.
Ensure accuracy and compliance of all documentation in accordance with data integrity standards and company policies.
Achieve PowerUser proficiency in supporting electronic systems (e.g., MasterControl).
Perform inventory management activities for consumables, media, cryovials, and other materials.
Assist with material procurement, receipt, and traceability.
Train colleagues on foundational process steps, equipment operation, and support tasks.
Maintain a safe and compliant working environment, ensuring adherence to all SOPs and industry best practices.
Participate in continuous improvement initiatives and process optimization projects.
Effectively manage time and multitask to meet production and documentation deadlines.