Manufacturing Associate II

Job Description

Job Description

"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 II who believe in the potential bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level.

The Manufacturing Associate II 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 II 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.

THE ROLE

• 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
• Conduct 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 to the attention of a supervisor.
• Ensures relevant manufacturing data are captured appropriately and accurately for supporting
• regulatory filings for clinical trials
• Inform Supervisor of equipment needs and supplies required to avoid interruption in processes
• Tagging out / equipment for recalibration.
• SME of routine maintenance procedures.
• Ownership of calibration schedule; collaborating with F&E
• Routine monitoring and troubleshooting of equipment, with appropriate escalation if necessary.
• Other tasks as assigned

THE CANDIDATE

PHYSICAL DEMANDS

WORK ENVIRONMENT

POSITION BENEFITS

"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"

Notice to Agency and Search Firm Representatives

Cellipont Bioservices is not accepting unsolicited resumes from agencies and / or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and / or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.