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Job Locations US-NJ-Florham Park
Come join us at our new state-of-the-art facility in Florham Park NJ!  The Microbiology Lead QC is responsible for providing oversight of Microbiology team staff members by ensuring daily microbiology testing is correctly scheduled and completed to support release of clinical and commercial products.  The required testing includes but is not limited to Environmental Monitoring (EM), growth promotion, endotoxin, plate reads, and microbial identification.  Perform routine microbial analysis to detect microbial content on test articles and on samples collected throughout the laboratories to obtain information on types, levels, and control of contamination as needed to support laboratory staff.  Interpret and review of microbiology testing data.  Participate in gowning qualifications, Aseptic Process Simulations (APS), Environmental Monitoring Performance Qualification (EMPQ),  In addition, assist with development of new microbiology related testing methods in-house and training of personnel.  This opportunity presents the ability to independently perform responsibilities in compliance with Celularity’s procedures, federal, state laws, and in accordance with current Good Manufacturing Procedures (cGMP), USP and other regulatory agencies.  Generate and evaluate trend reports to determine corrective actions as needed and also analyze data to provide appropriate next steps.  Composes procedures, protocols, final reports, investigations and associated Corrective and Preventive Actions (CAPAs). 
Category
Quality Control
ID
2020-1243
Job Locations US-NJ-Florham Park
Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com). Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.   As a QMS Coordinator, Contractor, you will work across the organization as a direct liaison between all departments and our quality unit within the quality management system. You will be part of current quality processes for QxP documents and records, and have the opportunity to be part of future improvements and automation efforts for these processes.
Category
Quality
ID
2020-1239
Job Locations US-NJ-Florham Park
Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.   As a Contractor Coordinator within QA, you will interface on a daily basis with manufacturing and QC personnel in the heart of the production area, the touchdown room.  The role will ensure proper release of cleanroom suites for manufacturing use and the critical issuance, tracking, reconciliation and coordinating of documents and labels used within the cleanroom suites. In addition, organization and detail-oriented skills will be used to review batch records and facilitate the release of clinical drug products.
Category
Quality
ID
2020-1233
Job Locations US-NJ-Florham Park
Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.   As aSr. Specialist, Contractor, within QA, you will be responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. This includes review of batch records and label reconciliation for product release, inspection/release of materials, review of change controls, deviations and investigations, and review of laboratory equipment qualifications. Other duties include tracking quality records, participation in internal/external audits, and overall Current Good Manufacturing Practices (cGMP) compliance.
Category
Quality
ID
2020-1232
Job Locations US-NJ-Florham Park
Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.    As an Associate Manager, New Product Introduction (NPI) Contractor within QA, you will provide quality guidance and support all new research and development activities and associated R&D manufacturing processes, including PD/CMC activities. The candidate will serve as a key player in establishing and maintaining quality systems associated with product development conducted under GMP, including the production, and testing of R&D materials.  Experience with creation, review and approval of technical transfer documents, standard operating procedures, test methods, batch records and other GMP documentation are required.  Experience with medical device product development and testing is preferred. This candidate will be expected to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory Affairs and Manufacturing.   
Category
Quality
ID
2020-1231
Job Locations US-NJ-Florham Park
Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.   As a Manager within Quality Systems, Contractor, you will provide day-to-day quality support, management, leadership and guidance across the organization with focus on documentation and training programs. As Business Process Owner, you will institutionalize and expand processes and automation, which includes L&D, document control and records management, to deliver required information to the relevant users when they need it in an effective, efficient and compliant way.  
Category
Quality
ID
2020-1230
Job Locations US-NJ-Florham Park
Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.    As a Manager within QA, you will be providing Quality Engineering guidance and oversight for the Drug Product and Tissue Manufacturing activities to ensure adherence to GTP standards and cGMP regulations. This role will provide the opportunity to collaborate with manufacturing, quality control, facilities, validation, and leaders across the organization, manage quality assurance processes and promote a right first-time quality culture.   
Category
Quality
ID
2020-1229
Job Locations US-NJ-Florham Park
Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.   As a Quality Engineer (Specialist) within QA,  you will provide day-to-day quality support and guidance in problem-solving and implementing solutions impacting equipment, facility, quality assurance and manufacturing processes.  You will also help institute statistical concepts and best practices for GxP activities as well as perform batch record reviews on tissue and drug products as needed.  
Category
Quality
ID
2020-1228
Job Locations US-NJ-Florham Park
  Under the minimal supervision of the Research Project Leader, the Senior Associate Scientist will be responsible for all research activities related to the development, optimization, and definition of cell culture processes and characterization of a next-generation, cell-based immunotherapy. Working independently, the successful candidate will be responsible for the experimental design and execution of key scientific studies, as well as analysis, critical interpretation, and documentation, including regular reports and both written and oral presentations of research results and progress. The Senior Associate Scientist will have strong background knowledge in the areas of molecular, cell, cancer, and immune biology, and expertise in immune cell process and assay development.    
Category
Research & Early Development
ID
2020-1226
Job Locations US-NJ-Florham Park
Exciting opportunity to work with a growing biotech company in a new, state-of-the-art facility located in Florham Park, NJ. Reporting to the Associate Director, Clinical Manufacturing, this role will participate in the day-to-day manufacturing of cellular supply for the company’s clinical programs and participate in pre-clinical supply campaigns as required.
Category
Technical Operations/ Manufacturing
ID
2020-1224
Job Locations US-NJ-Florham Park
  Celularity is a leading clinical stage NJ-based biotechnology company in cellular therapeutics.  The Translational Research group is seeking a highly motivated Scientist to lead translational research studies in support of Celularity’s ongoing Phase I/II clinical trials in cellular therapy. The candidate will have 2+ years of postgraduate academic or pharmaceutical industry experience in the field of immunology.  Expertise with multiparameter flow cytometry characterizing immune cell subsets in peripheral blood and/or tissue is required.  Prior experience working with human samples and immunoassay development is also necessary.  Prior experience working with high dimensional flow cytometry datasets is preferred.  The candidate will collaborate within the translational research team on the performance and analysis of datasets related to flow cytometry, ELISA/Luminex, functional assays, next-generation sequencing, and immunohistochemistry.  The candidate will also work closely with Celularity’s clinical team in communicating research results, alignment of sample logistics, maintaining communication with external CROs, and the design of follow up translational research studies.
Category
Research & Early Development
ID
2020-1222
Job Locations US-NJ-Warren | US-NJ-Florham Park
Reporting to the Analytical Development Lead, the Analytical Development Associate will perform cell-based assays, immuno-assays, aseptic cell culture maintenance, and flow cytometry analyses to support the development of clinical stage cell therapy products in the Process Development & CMC Group.   Responsibilities include cell culture initiation and maintenance, assay development, troubleshooting, stock/supplies tracking and maintenance, and implementation of cell-based and other functional methods for process and product characterization.  Key assays will include potency, identity, purity, and any other release testing required to ensure consistent production.  This individual will generate data and employ innovative methods to develop robust assays that are based on sound scientific rationale and aligned with regulatory requirements and current guidance.
Category
Process Development / CMC
ID
2020-1221
Job Locations US-NJ-Florham Park
Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular medicines for cancer, infectious diseases, and degenerative diseases (www.celularity.com).  We are expanding and looking for regulatory affairs talents who can join our mission in leading the next evolution in cellular medicine.   Director, Regulatory Affairs   The ideal candidate will be responsible for developing, optimizing, and implementing regulatory strategy and regulatory plan for assigned development programs.  The candidate will liaise with the US FDA and other global health authorities to facilitate product development, and ensure high-quality regulatory submissions, and timely clearance or approval of INDs, CTAs and marketing applications.   
Category
Regulatory
ID
2020-1219
Job Locations US-NJ-Florham Park
Excellent opportunity to work with a growing biotech company in a state-of-the-art facility in Florham Park, NJ.  Reporting directly to the Sr. Manager, Materials Management & Supply Chain, the Materials Management Supervisor will be responsible for supporting all manufacturing inventory activities for CMO, GMP, and GTP operations. This individual is expected to efficiently plan, organize, and control the work activities of materials management, warehouse, and shipping and receiving functional areas. Responsibilities include assessment of materials flow, inventory levels, purchasing activities related to inventory raw materials, and the day to day operations and supervision of direct and indirect reports.
Category
Technical Operations/ Manufacturing
ID
2020-1216
Job Locations US-NJ-Florham Park
Celularity is a New Jersey-based clinical-stage cell therapeutics company striving to become a leader in cellular therapeutics. We are looking for highly motivated and experienced Bioengineer Contractor to join our R&D team developing novel biomaterials, cells, exosomes and other biotherapeutics derived from postpartum tissue, applicable across unmet clinical needs. The PD Engineer will conduct process development, optimization, scale up and transfer of the qualified pilot scale processes to the commercial manufacturing site.
Category
ART
ID
2020-1215
Job Locations US-NJ-Florham Park
Celularity is a New Jersey-based clinical-stage cell therapeutics company striving to become a leader in cellular therapeutics. We are seeking a highly motivated and innovative Research Scientist Analytical Characterization Contractor to join our R&D team developing novel implantable biomaterials, cells, exosomes and other innovative biotherapeutics derived from postpartum tissue, applicable across unmet clinical needs.   The Research Scientist Contractor will conduct analytical and physico/mechanical product characterization to support process development efforts. This position will advance our ability to develop and transfer processes to GMP manufacturing, by providing analytical characterization of various biological modalities, including decellularized allograft tissues, natural/synthetic composite implantable devices, cells, and exosomes.
Category
Research & Early Development
ID
2020-1214
Job Locations US-NJ-Warren | US-Florham Park
We are looking for a motivated Sr. Scientist to join our Process Development and CMC group to lead the development and tech transfer of processes for clinical stage cell therapy products. This position requires hands-on execution of process optimization and characterization of cell culture processes as well as the leadership to transfer the processes to the manufacturing operations team. Furthermore, this individual is expected to work independently on assigned tasks/projects and provide insight to improve processes and communicate results to the corresponding project team. Ideal candidates will have demonstrated process development and tech transfer experience in cell therapyand will be detail-oriented with excellent organization, documentation, and communication skills.
Category
Process Development / CMC
ID
2020-1211
Job Locations US-NJ-Florham Park
Exciting opportunity to work in our state-of-the-art facility located in Florham Park, NJ.  The QC Associate is responsible for supporting Quality Control microbiology testing for release of clinical and commercial products and environmental monitoring. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay development/implementation.
Category
Quality Control
ID
2020-1208
Job Locations US-NJ-Florham Park
  This position leads cell therapy hematology/oncology studies in study design, data analysis and interpretation of results independently with minimal supervision. This position provides input to entire drug development plans and authors regulatory responses and other documents with minimal supervision. This position interacts with project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians.
Category
Clinical Development
ID
2020-1202
Job Locations US-Florham Park
Exciting opportunity to work in our new state of the art office located in Florham Park, NJ.  Reporting directly to the Sr. Manager, Materials Management & Supply Chain, the Material Support Associate will be responsible for conducting, labeling, packaging, and production support activities to support commercial and clinical manufacturing. This individual is expected to work hands on under ISO 7, ISO 8, and other classified areas with a and variety of manufacturing production equipment technology.  Responsibilities include supplying materials to internal customers, maintaining controlled storage location of operations and fulfillment, perform routine inventory transaction in the ERP system, and distribution of manufacturing processing kits.
Category
Technical Operations/ Manufacturing
ID
2020-1201