Operator, Clinical Manufacturing

Job Description

Job Description

Description:

About Celularity

Celularity is a biotechnology company developing off-the-shelf placental-derived allogeneic cell therapies including genetically modified and unmodified NK cells, engineered T cells including CAR-T cells, and mesenchymal-like adherent stromal cells (ASCs), targeting indications across cancer, immunologic, infectious, and degenerative diseases.

Summary

Celularity is seeking a dynamic individual to join a motivated team of clinical operators for the daily manufacture of multiple cell therapy products in support of clinical stage platforms and collaborations. Leveraging Celularity’s state-of-the-art cGMP capable facility, this position will make use of existing innovations and future technologies to meet and exceed manufacturing demand.

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

• Joining a team of highly qualified operators, participate in the daily, technical manufacture of cell therapy 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 cell therapies. Maintain and deliver sufficient supply of cellular products for clinical studies and/or 3rd part collaborations in accordance with timelines and participate in clinical supply campaigns.
• 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.
• Participate 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.
• Routinely prepare and maintain cell culture reagents and media. Establish ongoing supply of donor cell stock and master cell banks as required.
• 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.

Minimum Qualifications (Must have)

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

Preferred Qualifications

• 1-2 years’ relevant experience with clinical 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)
• 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

Working Conditions

• Position primarily operates for extended periods of time in laboratory environments. Daily gowning in company provided scrubs, PPE, etc.
• Fast paced, start-up environment which may periodically require work beyond standard business hours.
• Must be able to lift and transport at least 50 pounds .
• Handling of potentially biohazardous material (human cells, tissues, etc.).
• Daily tasks call for routine walking and standing in cleanroom environments and occasional lifting of heavy materials.

Cleanroom/Laboratory Health and Hygiene Requirements for the role include but are not limited to:

• Adherence to stringent health and hygiene standards : Personnel must comply with strict cleanliness protocols to ensure the integrity of Celularity's controlled environments and contamination control policies.
• Personal hygiene : Regular personal hygiene practices are required, including frequent bathing, handwashing, and maintaining clean, trimmed hair (including facial hair) and nails to minimize contamination risks.
• Health status : Employees exhibiting symptoms of illness, including colds, infections, or other conditions that could lead to contamination, are prohibited from entering cleanroom environments to safeguard product quality and safety.
• Dress Code Compliance: The use of makeup, false eye lashes, nail polish/gel, hair spray, temporary or semi-permanent hair dyes, jewelry, or any other personal items that may transfer contaminants is strictly prohibited in cleanroom and laboratory environments.
• Training and gowning : Successful completion of regular gowning qualifications is mandatory. Employees must demonstrate continuous adherence to gowning procedures and all established cleanliness and hygiene protocols to maintain a sterile environment.

Celularity Inc. is an equal opportunity employer