Manufacturing Associate II

Cellipont Bioservices•The Woodlands, TX

About The Position

Cellipont Bioservices is seeking a Manufacturing Associate II to assist with planning and timely execution of manufacturing operations at a cGMP-compliant cell processing and clinical manufacturing facility. The role emphasizes primary cell isolation and cell culture in an aseptic processing environment, and requires following facility practices and applicable regulatory requirements for materials used in clinical studies, trials, and products. The associate supports operation of the GMP cell manufacturing plant in accordance with applicable FDA, ISO, Environmental Health & Safety, Human Resources, EMA, and other quality-system requirements. The role helps maintain compliant production areas, processes, and procedures; supports manufacturing with ancillary laboratory and equipment tasks; and contributes to safety, quality, accountability, cost efficiency, timely delivery, and customer service. Responsibilities also include maintaining facility readiness, identifying and escalating risks, accurately capturing manufacturing data for clinical-trial regulatory filings, monitoring and troubleshooting equipment, and owning calibration scheduling in collaboration with Facilities & Engineering. The position requires flexibility to work variable hours and schedules as production demands require. Work may include cleanroom assignments of up to 4–6 hours at a time, with required protective gowning. The role offers career development, cross-functional exposure, and a benefits package.

Requirements

At least 2 years of direct experience in cell manufacturing or commercial biologic drug manufacturing operations in a GMP environment.
At least 2 years of direct experience in manufacturing operations, with the ability to lead by example and help train other manufacturing technicians.
Understanding of GMP and GDP requirements.
Excellent time-management and organizational skills, including the ability to prioritize multiple projects and meet deadlines.
Ability and willingness to problem-solve and diagnose process, product, or equipment issues.
Excellent oral and written communication skills, including strong technical writing ability.
High motivation; ability to follow oral and written instructions, communicate effectively, think logically, and work independently or in a fast-paced team environment.
Proficiency in Microsoft Word and Excel.
Ability to work flexible hours and inconsistent schedules as needed to meet production demands and timelines.

Nice To Haves

Bachelor’s degree in Life Sciences, preferred, with demonstrated technical experience in bioprocessing, cell line engineering, or tissue engineering.
Experience with Microsoft Projects and Visio.

Responsibilities

Assist with planning and timely execution of manufacturing operations for a cGMP-compliant cell processing and clinical manufacturing facility.
Support operation of the GMP cell manufacturing plant in accordance with applicable FDA, ISO, Environmental Health & Safety, Human Resources, EMA, and quality-system requirements.
Maintain production areas, processes, and procedures in compliance with internal and external requirements and operating standards.
Conduct ancillary processing support, including laboratory and equipment cleaning and maintenance, inventory management and stocking, and preparation of shipping and packaging materials.
Promote a culture of safety, quality, accountability, cost efficiency, on-time delivery, and customer service.
Maintain facilities in a continuous state of readiness, identify and mitigate operational risks, and promptly raise concerns with a supervisor.
Capture manufacturing data accurately and appropriately to support regulatory filings for clinical trials.
Inform the supervisor of equipment and supply needs to help avoid process interruptions.
Tag equipment out for recalibration.
Serve as a subject matter expert for routine maintenance procedures.
Own the calibration schedule in collaboration with Facilities & Engineering.
Monitor and troubleshoot equipment routinely, escalating issues when appropriate.
Perform other tasks as assigned.

Benefits

Opportunities for career growth within an expanding team.
Defined career path and annual performance review and feedback process.
Cross-functional exposure to other areas of the organization.
Robust benefits package designed for health and wellness needs, including coverage for pets.
Strong employer 401(k) match.
Tuition reimbursement.
Employee referral bonuses.
Flexible work schedules and PTO based on role and level; PTO increases by one day each year.
Paid holidays.
Experience in the cutting-edge cell therapy space.