Sterility Assurance Manager

2 weeks ago

Florham Park, United States Celularity, Inc. Full time

Job Description

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 Sterility Assurance Manager is responsible for ensuring the sterility and microbiological integrity of pharmaceutical products throughout the manufacturing process. This role involves developing, implementing, and maintaining sterility assurance programs and procedures to comply with regulatory requirements and industry standards. The Sterility Assurance Manager will lead a team of professionals to conduct microbiological testing, monitor environmental conditions, and investigate deviations to prevent contamination and ensure product safety.

Responsibilities will include, but are not limited to, the following: Develop and implement sterility assurance programs, policies, and procedures in compliance with regulatory guidelines (e.g., FDA, EMA). Indirectly lead and coach those entering cleanroom environments, authoring procedures and providing guidance, training, and support as needed. Oversee environmental monitoring programs to ensure cleanliness and sterility of manufacturing facilities. Co-Lead investigation into sterility failures, deviations, and out-of-specification results, and implement corrective and preventive actions (CAPAs) as necessary. Collaborate with cross-functional teams, including Quality Control, Manufacturing, and Regulatory Affairs, to ensure alignment and consistency in sterility assurance practices. Review and approve sterilization validation protocols, reports, and related documentation. Stay informed about advancements in sterilization technologies, microbiological testing methods, and regulatory requirements, and incorporate best practices into sterility assurance programs. Be the key Subject Matter Expert during regulatory inspections, accreditation audits and customer audits, providing support and documentation as needed. Drive continuous improvement initiatives to enhance sterility assurance processes and mitigate risks. Identify and mitigate risks which have potential to impact sterility assurance. Implement strategies to address any issues or challenges encountered during the validation process. Perform regular review of sterility assurance related metrics to present at Management Review meetings and routine meetings / dashboards. Requirements:

Education and Experience Bachelor’s degree in Microbiology, Biology, Pharmacy, or related field; advanced degree preferred. Minimum of 5 years of experience in sterility assurance or microbiology within the pharmaceutical or biotechnology industry. Strong working knowledge of sterility requirements in a GXP environment. Strong understanding of sterilization methods, aseptic processing techniques, and aseptic behavior expectations in cleanroom environments. Familiarity with regulatory requirements and guidelines governing sterility assurance, such as cGMP, ISO, and USP. Excellent leadership, communication, and problem-solving skills. Ability to manage multiple projects simultaneously and prioritize tasks effectively. Experience with quality management systems (e.g., Veeva, TrackWise) is preferred. Strong knowledge of ICH Q9 Quality Risk Management as it applies to phase-appropriate method development and validation preferred. Certification in Quality Assurance or Sterility Assurance (e.g., ASQ, PDA) is a plus.

Working Conditions The incumbent will be working in an office environment but will often visit and engage with manufacturing personnel in the laboratories. Flexible scheduling required. Some light lifting may be required occasionally. Must be able to gown aseptically. Must be authorized to work directly for Celularity in the U.S.

No agency submittals accepted through this website.

Celularity Inc. is an equal opportunity employer

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