Manufacturing Associate II

Job Summary Cellipont Bioservices is growing, and we are looking for a Manufacturing Associate II who believes in bringing our client's discoveries to patient cures and who wants to challenge the status quo and help take Cellipont and its clients to the next level. The Manufacturing Associate II assists 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 Role Assist 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. Ensure 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, such as lab and equipment cleaning and maintenance, inventory management and stocking, and preparing shipping/packaging materials. Maintain a strong culture of safety, quality, accountability, cost efficiency, on‑time delivery and customer service. Ensure facilities are maintained in a continuous state of readiness, identify and mitigate risks for the operation and bring them to the attention of a supervisor in a timely manner. Capture relevant manufacturing data accurately for supporting regulatory filings for clinical trials. Inform the supervisor of equipment needs and supplies required to avoid interruptions in processes. Coordinate equipment tagging out and recalibration. Serve as subject‑matter expert of routine maintenance procedures. Own the calibration schedule and collaborate with Facilities & Engineering. Perform routine monitoring and troubleshooting of equipment, escalating as necessary. Perform other tasks as assigned. The Candidate Bachelor’s Degree in Life Sciences preferred, with demonstrated technical experience in bioprocessing, cell line engineering or tissue engineering. At least 2 years of direct experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment. At least 2 years of direct experience working within manufacturing operations and leading by example, capable of training other manufacturing technicians. Understanding of GMP and GDP requirements. Excellent time‑management and organizational skills, with the ability to manage and prioritize multiple projects and meet deadlines. Willingness to problem‑solve and diagnose process/product/equipment problems. Excellent oral and written communication skills, with strong technical writing ability. High motivation, ability to follow oral and written instructions, communicate effectively, think logically, and thrive independently or in a fast‑paced team environment. Proficient in Microsoft Word and Excel; experience with Microsoft Projects and Visio preferred. Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines. Physical Demands Frequently required to stand and/or sit for extended periods; occasionally required to walk, have high levels of hand/finger dexterity, climb or balance and stoop, kneel, crouch or crawl. Occasionally required to lift and/or move up to 25 pounds. Work Environment Occasionally exposed to moving mechanical parts, biological materials or caustic cleaning chemicals, strong magnets, and sensitive calibrated equipment. Noise level is usually moderate. A marginal amount of work is completed in a cleanroom environment; employees may be expected to work in cleanroom conditions for up to 4–6 hours at a time. Gowning requirements include 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 within the organization. Robust benefit package designed for unique health and wellness needs, including coverage for pets. 401(k) with strong employer match. Tuition reimbursement. Employee referral bonuses. Flexible work schedules and PTO based on role/level, with 1 additional PTO day each year and paid holidays. Gain experience in the cutting‑edge cell therapy space. #J-18808-Ljbffr Cellipont Bioservices