Folder Operator Assistant jobs in Newark, NJ

Description

About Celularity Inc.

 Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases. Celularity is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor ("CAR"), natural killer ("NK") cells, and mesenchymal-like adherent stromal cells ("MLASCs") and exosomes. These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics. 

Summary

Come join our team and work in our new, state-of-the-art facility located in Florham Park, NJ.  The Operator, Microbiology, is responsible for microbiology testing for the release of clinical and commercial products and environmental monitoring. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and microbiology assay development/implementation.

Requirements

Responsibilities

• Perform routine laboratory, GTP and GMP environmental monitoring, data entry, data review and product release testing in timely manner.  Operate in ISO 5 / 7 classified manufacturing environments, cleanroom suites and supporting areas.  Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of testing. 
• Understand  and perform principles of aseptic gowning, including the use of scrub  suits, cover gowns, and/or Tyvek suite in various clinical manufacturing laboratories.  Ability to gown appropriately for cleanroom/GMP manufacturing is required with passing rounds of gowning qualifications to obtain clearance into the cGMP laboratories.
• Perform on-the-job training and annual qualifications to new hire and microbiology / manufacturing associates.
• Ability to adhere to Good Documentation Practices. Execution and daily completion of multiple environmental monitoring records and entry of data into electronic databases.  Consistently perform various laboratory duties and aseptically test time sensitive material with accuracy and precision.  
• Execute SOPs/protocols to support Quality Control Operations.  As needed, provide daily technical updates to management.  Provide input during team review of technical documents, such as SOPs.
• Initiate / write deviation / investigation, OOS in approved system.
• Concentrate with great attention to details, good focus, and ability to perform repetitive technical tasks.  Ability to accurately and completely understand, follow, and apply cGMP requirements with on-the-job training.
• Familiarity with various microbiology and environmental monitoring techniques and equipment through education and/or industry experience.  Ability to assist with technical writing and data trending.
• Problem solving ability/mentality, technically adept, and logical with strong organization skills.
• Capacity to communicate effectively with peers, department management, and cross-function peers to ensure all timelines are met.
• Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.

Qualifications:

Education and Experience

• BS degree in Biology or related scientific discipline, ideally a microbiology background. An equivalent combination of education and experience may substitute.
• Strong organizational and time management skills.
• Ability to work well in a team environment.
• Excellent verbal and written communication skills as well as strong focus and attention to detail.
• Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for aseptic gowning, routine walking and standing in cleanroom environments and occasional lifting of heavy materials.
• Flexible scheduling required, occasional weekend and off-hour coverage is required.

Preferred Qualifications  

• Minimum of 1 years of relevant experience with Environmental Monitoring within cGMP environments.
• Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211) including Gowning Qualifications
• Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts.
• Understanding of clinical cGMP manufacturing operations and related gowning
• Knowledge of GxP regulations (cGTP, cGDP, cGMP)
• Independent and self-starting. 
• Eager, flexible availability and adaptable

Working Conditions 

• Position primarily operates for extended periods of time in classified cleanroom environments. Daily gowning in company provided scrubs, PPE, and clean room attire.
• A  fast paced, start-up environment which may periodically require work beyond standard business hours and mealtimes may slightly shift due to cleanroom manufacturing timelines.
• Working later/off hours and weekends will be required in order to support our microbiology laboratory’s activities, manufacturing activities and qualifications.
• Must be able to lift and transport at least 25 pounds on a daily routine basis.