Manufacturing Associate III

Cellipont Bioservices•The Woodlands, TX

2d•$34 - $38•Onsite

About The Position

Cellipont Bioservices is seeking a Manufacturing Associate III who is passionate about advancing cell therapies from discovery to patient cures. This role involves assisting in the planning and execution of manufacturing operations within a cGMP-compliant facility, focusing on primary cell isolation and cell culture in an aseptic environment. The Manufacturing Associate III will adhere to standard practices and regulatory requirements for manufacturing clinical trial materials.

Requirements

Bachelors Degree in the Biologic Sciences or Bioengineering, with demonstrated technical experience in Bioprocessing, Cell Line Engineering or Tissue Engineering.
3+ years of direct experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMP environment.
3+ 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.
Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.

Nice To Haves

Experience in Microsoft Projects, Visio.

Responsibilities

Assist in 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 and identify/mitigate risks, bringing them to the attention of a supervisor.
Ensure relevant manufacturing data is captured appropriately and accurately for supporting regulatory filings for clinical trials.
Discover and implement continuous improvement projects that enhance department safety and efficiency.
Perform expert-level aseptic processing.
Train new associates in process flows and aseptic techniques.
Serve as a Subject Matter Expert (SME) of manufacturing processes and procedures.

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
Paid holidays
Gain experience in the cutting-edge cell therapy space