Operator, Manufacturing

Job Description

Description:

About Celularity

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

The Operator, Manufacturing has responsibility for the daily manufacture of cell products in support of the company’s commercial and clinical platforms. Leveraging existing and future technology, the Operator will work within the Manufacturing Operations team in a fast-paced, dynamic work setting to support daily production demand and contribute to core departmental objectives.

Responsibilities will include, but are not limited to, the following:

Technical processing of multiple biological products with direct involvement in the development, production, storage and release of these products.

Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of all manufactured products. Maintain and deliver sufficient supply of cellular products in support of company goals and timelines.

Operate in classified manufacturing environments and clean room suites. Ability to gown appropriately for clean room/aseptic manufacturing is required.

Execution and daily completion of multiple batch records and entry of data into electronic databases. Ability to adhere to Good Documentation Practices.

Consistently perform various clean room duties and techniques on time sensitive material with accurate and precise manipulations.

Ensure the proper operation and performance of manufacturing equipment and accurately complete equipment logbooks and associated records.

Participate in non-conformance investigations and CAPA determination with the focus on determining root cause.

Assemble, document and transfer processing kits to all laboratories. Maintain production kit supply levels and assure proper consumable control.

Work with Production Leads in the implementation of departmental improvements and changes.

As required, participate in the manufacturing environment cleaning program and work to assure all manufacturing suites, equipment and critical environments are maintained on schedule and per qualified methods.

Requirements:

Skills/Knowledge Required:

Required:

B.S degree in Biology, Bioengineering or related scientific discipline

Experience with clean room operation and aseptic technique

Strong organizational and time management skills

Ability to work well in a team environment

Flexible scheduling required. Periodic weekend/holiday work probable

Dynamic individual with the ability to communicate and engage others

Independent and self-starting.

Eager and adaptable

Desired:

1-2 years' experience with human cells production/manufacturing

Knowledge of GLP/GDP/GMP