Operator, Tissue Manufacturing - Temp to Perm

Celularity•Florham Park, NJ

5d•$58,000 - $62,000•Onsite

About The Position

About Celularity: Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties, and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease. Summary: Celularity is seeking a dynamic individual to join a motivated team of clinical operators for the daily manufacture of multiple tissue product. Leveraging Celularity’s new, state-of-the-art cGMP capable facility, this position will make use of existing innovations and future technologies to meet and exceed manufacturing demand.

Requirements

Experience with cells and/or tissue manufacturing.
Understanding of human cell and tissue-based therapies
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 routine walking and standing in cleanroom environments and occasional lifting of heavy materials.
Flexible scheduling required

Nice To Haves

B.S degree in Biology, Bioengineering or related scientific discipline, or equivalent experience
1-2 years’ relevant experience with tissue manufacturing and operation within cGMP environments.
Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
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)
Knowledge of procedure and batch record writing and creation.
Experience in a fast-paced, scientific start-up environment
Dynamic individual with the ability to communicate and engage others
Independent and self-starting.
Eager and adaptable

Responsibilities

Joining a team of highly qualified operators, participate in the daily, technical manufacture of the company’s tissue products.
Operate in classified manufacturing environments and clean room suites.
Ability to gown appropriately for clean room/aseptic manufacturing is required.
Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of all manufactured tissue products.
Technical processing of multiple tissue products with direct involvement in harvesting, processing, storage and release.
Maintain and deliver sufficient supply of tissue products per internal sales forecast.
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.
Direct involvement in process development, training activities and technical process transfers for existing and future products.
Execute protocols to support manufacturing operations.
As needed, provide daily technical updates to Technical Operations management.
Ensure the proper operation and performance of manufacturing equipment and accurately complete equipment logbooks and associated records.
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