Manufacturing Associate III

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“Bridging Innovation to Cure.”

“Developing and Manufacturing your cell therapies from benchtop to bedside.”

Job Summary

Cellipont Bioservices is growing, and we are looking for a Manufacturing Associate III who believes in the potential of bridging clients’ discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.

The Manufacturing Associate III is responsible for assisting in the planning and timely execution of manufacturing operations for a cGMP-compliant state-of-the-art cell processing/clinical manufacturing facility with emphasis on primary cell isolation and cell culture in an aseptic processing environment.

The Manufacturing Associate III is responsible for following the standard practices outlined for the operation of the facility in accordance with the regulatory requirements for the manufacture of materials for our clinical studies, clinical trials and products.

• Assists the operation of a state-of-the-art GMP cell manufacturing plant in accordance with FDA, ISO, Environmental Health & Safety, Human Resources, EMA regulations and other Quality System regulations, as applicable
• Ensures production area, processes and procedures are maintained in compliance with internal and external compliance and operating standards
• Conducts ancillary activities in support of processing functions, e.g., lab and equipment cleaning and maintenance, inventory management and stocking, preparing shipping/packaging materials
• Maintains a strong culture of safety, quality, accountability, cost efficiency, on‑time delivery and customer service
• Ensures facilities are maintained in a continuous state of readiness. Identifies and mitigates risks for the operation and timely brings them to the attention of a supervisor
• Ensures relevant manufacturing data are captured appropriately and accurately for supporting regulatory filings for clinical trials
• Discover/implement continuous improvement projects that improve department safety and efficiency
• Expert level aseptic processing
• Trains new associates in process flows and aseptic techniques
• Subject matter expert of manufacturing processes and procedures

• Bachelor’s Degree in the Biologic Sciences or Bioengineering, with demonstrated technical experience in Bioprocessing, Cell Line Engineering or Tissue Engineering
• 3+ years of direct experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment
• 3+ years of direct experience working within manufacturing operations and leading by example; capable of helping to train other manufacturing technicians
• Understanding of GMP and GDP requirements
• Excellent time management and organizational skills, demonstrated ability to manage and prioritize multiple projects and meet deadlines
• Willingness to problem solve and/or diagnose process/product/equipment problems
• Excellent oral and written communication skills. Strong technical writing ability required
• Highly motivated, follows oral and written instructions, communicates effectively, thinks logically, and thrives independently and/or in a fast‑paced team environment
• Proficient in Microsoft Word and Excel. Experience in Microsoft Projects and Visio preferred
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines

• While performing the duties of this job, the employee is frequently required to stand and/or sit for extended periods. The employee is occasionally required to walk; has high levels of hand/finger dexterity; climbs or balances and stoops, kneels, crouches, or crawls.
• The employee must occasionally lift and/or move up to 25 pounds

• While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; biological materials or caustic cleaning chemicals; strong magnets; and sensitive calibrated equipment.
• Noise level in the work environment is usually moderate
• A marginal amount of the work is completed in a cleanroom environment;…