Manufacturing Associate II

JOB SUMMARY

Cellipont Bioservices is growing, and we are looking for aManufacturing 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

• Bachelors Degree in Life Sciences preferred, with demonstrated technical experience in Bioprocessing, Cell Line Engineering or Tissue Engineering.
• 2+ years of direct experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment
• 2+ 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
• Able to demonstrate willingness to problem solve and/or diagnose process/product/equipment problems
• Excellent oral and written communication skills. Strong technical writing ability required
• Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment
• Must be proficient in Microsoft Word and Excel. Experience in Microsoft Projects, Visio, and preferred
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines

PHYSICAL DEMANDS

• 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; have high levels of hand/finger dexterity; climb or balance and stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 25 pounds

WORK ENVIRONMENT

• 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; employees may be expected to work in clean room conditions for up to 4-6 hours at a time.
• While working in the area the gowning requirements are safety goggles, shoe covers, hood, gown, mask, boots and gloves.
• Working conditions can include standing for long periods of time.

POSITION BENEFITS

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
• 401K strong employer match
• Tuition Reimbursement
• Employee Referral Bonuses
• Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
• Gain experience in the cutting-edge cell therapy space