Cell Therapy Manufacturing Specialist

Job Description

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.

Aseptic Processing & Cell Culture Operations

• 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.

Documentation, Compliance & Quality

• 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 Power User proficiency in supporting electronic systems (e.g., Master Control).

Operational Support & Collaboration

• 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.

Qualifications

Education

• Bachelor’s degree in a scientific discipline or equivalent direct industry experience.

Experience & Skills

• 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.

• 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.