Job Description

Overview Celularity is a next-generation Biotechnology company creating off-the-shelf cellular medicines for Hematology/Oncology, Infectious Diseases, and Degenerative Diseases.  Our employees are experienced cellular medicine leaders and innovators and are revolutionizing the way the industry approaches disease.

This contractor role will participate in the day-to-day process development and bioprocessing of postpartum tissue-based products, cell therapy, exosomes, supporting the company's product development and commercial needs as well as participate in pre-clinical prototype generation campaigns, as required.

Responsibilities

• Participate in the daily processing of the company's postpartum tissue - based, cell therapy or exosome products, process development, improvements, feasibility, engineering and process validation and transfer runs.
• Operate in ISO 7 and ISO 8 (Class 10,000 and Class 100,000) process development environments. Ability to gown appropriately for clean room/aseptic manufacturing is required.
• Maintain and deliver sufficient supply of appropriate grade materials for regulatory submissions - enabling GLP biocompatibility and other validation studies in accordance with project timelines.
• Develop technical reports, data summaries, presentations, SOPs and batch records.
• Participate in the process development, training, and process transfers for existing and future products. Execute protocols to support product development operations.
• Participate in the process development equipment calibration to assure all equipment is maintained as per qualified methods, Complete multiple equipment logbooks.
• Consistently perform various manual laboratory duties and techniques on time sensitive materials with accurate and precise manipulations and data recording; Adhere to Good Documentation Practices.
• Execute and complete batch records.

Qualifications Required

• BS./M.S. in Biology, Bioengineering or related scientific discipline.
• 1- 2 years' relevant hands-on experience with decellularized tissue - based products, cell therapy or exosome process development, process transfer to manufacturing in cGMP environments.
• Understanding of federal regulations for Quality Systems and GMP manufacturing
• Excellent verbal and written communication skills as well as strong focus and attention to details.

Desired

• Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts
• Strong organizational and time management skills
• Dynamic individual with the ability to communicate and engage others
• Independent and self-starting. Ability to work with minimal supervision

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Company Description

At Celularity, we are on a mission to lead the next evolution in cellular medicine by delivering advanced off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity is fundamentally altering how we approach the treatment of cancer and infectious & degenerative diseases through continuous, innovative application of new discoveries in cellular medicine.