GMP Cell Therapy Manufacturing Associate II

Cellipont Bioservices; The Woodlands (TX); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Career growth opportunities

Annual performance review & feedback

Cross-functional exposure

401K employer match

Tuition reimbursement

Employee referral bonuses

Job summary

Cellipont Bioservices is seeking a Manufacturing Associate II to support planning and timely execution of manufacturing operations in a state-of-the-art cGMP facility. The role emphasizes primary cell isolation and aseptic cell culture, aligned with regulatory requirements for clinical studies and products.

The candidate will assist in maintaining compliant processes, collaborate with cross-functional teams, and contribute to safe, on-time cell therapy production while growing within a dynamic,

Qualifications

• Bachelor’s Degree in Life Sciences preferred with experience in Bioprocessing,Cell Line Engineering or Tissue Engineering.
• 2+ years in cell manufacturing/biologic drug manufacturing in GMP.
• 2+ years leading manufacturing operations and training technicians.
• Understanding of GMP and GDP requirements.
• Excellent time management and organizational skills for multiple projects.
• Problem-solving and diagnostic skills for processes/equipment.
• Strong written and verbal communication.
• Motivation, independent work and team adaptability.
• Proficient in Word/Excel; experience with Projects/Visio preferred.
• Ability to work flexible hours to meet production needs.

Responsibilities

• Assist operation of GMP cell manufacturing plant compliant with FDA/ISO/EMA regulations.
• Maintain production area and processes in compliance with standards.
• Perform ancillary activities: lab/equipment cleaning, inventory, packaging materials.
• Promote safety, quality, accountability, cost efficiency, on-time delivery, and customer service.
• Ensure readiness of facilities and identify operational risks.
• Capture manufacturing data for regulatory filings for clinical trials.
• Inform supervisor of equipment/supply needs to avoid interruptions.
• Tagging out equipment for recalibration; SME of routine maintenance.
• Own calibration schedule; collaborate with Facilities & Engineering.
• Routine monitoring and escalation of equipment issues.
• Other tasks as assigned.

Skills

Bioprocessing

Cell culture

GMP knowledge

Documentation

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft Projects/Visio

Job description

Cellipont Bioservices is seeking a Manufacturing Associate II to support planning and timely execution of manufacturing operations in a state-of-the-art cGMP facility. The role emphasizes primary cell isolation and aseptic cell culture, aligned with regulatory requirements for clinical studies and products.

The candidate will assist in maintaining compliant processes, collaborate with cross-functional teams, and contribute to safe, on-time cell therapy production while growing within a dynamic,