Manufacturing Associate II

Cellipont Bioservices; The Woodlands (TX); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Career growth opportunities

Annual performance review & feedback

Cross-functional exposure

401K employer match

Tuition reimbursement

Employee referral bonuses

Job summary

Cellipont Bioservices is seeking a Manufacturing Associate II to support planning and timely execution of manufacturing operations in a state-of-the-art cGMP facility. The role emphasizes primary cell isolation and aseptic cell culture, aligned with regulatory requirements for clinical studies and products.

The candidate will assist in maintaining compliant processes, collaborate with cross-functional teams, and contribute to safe, on-time cell therapy production while growing within a dynamic,

Qualifications

• Bachelor’s Degree in Life Sciences preferred with experience in Bioprocessing,Cell Line Engineering or Tissue Engineering.
• 2+ years in cell manufacturing/biologic drug manufacturing in GMP.
• 2+ years leading manufacturing operations and training technicians.
• Understanding of GMP and GDP requirements.
• Excellent time management and organizational skills for multiple projects.
• Problem-solving and diagnostic skills for processes/equipment.
• Strong written and verbal communication.
• Motivation, independent work and team adaptability.
• Proficient in Word/Excel; experience with Projects/Visio preferred.
• Ability to work flexible hours to meet production needs.

Responsibilities

• Assist operation of GMP cell manufacturing plant compliant with FDA/ISO/EMA regulations.
• Maintain production area and processes in compliance with standards.
• Perform ancillary activities: lab/equipment cleaning, inventory, packaging materials.
• Promote safety, quality, accountability, cost efficiency, on-time delivery, and customer service.
• Ensure readiness of facilities and identify operational risks.
• Capture manufacturing data for regulatory filings for clinical trials.
• Inform supervisor of equipment/supply needs to avoid interruptions.
• Tagging out equipment for recalibration; SME of routine maintenance.
• Own calibration schedule; collaborate with Facilities & Engineering.
• Routine monitoring and escalation of equipment issues.
• Other tasks as assigned.

Skills

Bioprocessing

Cell culture

GMP knowledge

Documentation

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft Projects/Visio

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

• 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

"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.