Manufacturing Associate II

Job Summary

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

• Assist in the operation of a state‑of‑the‑art GMP cell manufacturing plant in accordance with FDA, ISO, EHS, Human Resources, EMA regulations and other quality systems.
• 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 (lab and equipment cleaning, inventory management, stocking, 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 a supervisor’s attention.
• Ensure relevant manufacturing data are captured accurately for supporting regulatory filings for clinical trials.
• Inform supervisor of equipment needs and supplies to avoid interruption in processes.
• Tagging out / equipment for recalibration.
• Subject‑matter expert 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.

• Bachelor’s 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 in 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.
• Proficient in Microsoft Word and Excel; experience in Microsoft Projects, Visio preferred.
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.

• Employee is frequently required to stand and/or sit for extended periods; occasionally required to walk; high levels of hand/finger dexterity; climb or balance and stoop, kneel, crouch, or crawl.
• Employee must occasionally lift and/or move up to 25 pounds.

• Employee is occasionally exposed to moving mechanical parts; biological materials or caustic cleaning chemicals; strong magnets; and sensitive calibrated equipment.
• Noise level is usually moderate.
• 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.
• Standing for long periods of time is common.

• 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 & 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.

Entry level

Full‑time

Research, Analyst, and Information Technology

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.