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Celularity is seeking a dynamic, technical leader that will oversee the company’s cGMP microbiology function. This role will work cross-functionally with Manufacturing, Quality Assurance, Analytical QC and Process Development to support the manufacture and release of multiple cell therapy and human tissue products. Responsibilities include, but not limited to, the direct oversight of a dynamic Microbiology team, cleanroom qualifications and daily cleanroom release, personnel monitoring, gowning qualifications and compendial testing. All responsibilities are in support of continually ensuring a compliant, robust, and reproducible facility wide contamination control and microbiological program.
We are currently seeking a Scientist, Contractor to join our Analytical Development Group. The successful candidate should possess the knowledge and experience to independently perform cell-based assays, immuno-assays, aseptic cell culture initiation and maintenance, and flow cytometry-based characterization to support the development of our clinical stage cell therapy products.
Responsibilities will include the design and implementation of cell-based and other functional methods for process and product characterization. Key assays will include potency, cytotoxicity, 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.
The Manager, Internal Controls (SOX) is responsible for ensuring financial reporting risk is managed in accordance with applicable SEC and company requirements. He or she performs independent monitoring & testing assurance over select SOX key controls, assesses, evaluates, monitors and reports deficiencies, and supports the quarterly and annual CEO & CFO SOX certification process. This position is responsible in reviewing existing financial and internal business controls procedures, recommending control improvements. He/she will interface with executive management, business process owners, finance team and external auditors to establish the company's control environment and manage corporate risk to ensure assets and income streams are appropriately protected.
The Scientist position is responsible for providing scientific and technical leadership to enable the development of innovative and life-changing cellular immunotherapies within the R&D group. As a member of the Genetically Modified T cell (GMT) team, this scientist will design, execute, and manage studies to support the discovery and development of Immune-Oncology therapeutics to meet regulatory requirements for pre-IND and IND submissions. The successful individual will demonstrate subject matter expertise in molecular, cell, cancer and immune cell biology and hands-on experience in immune cell therapy process and assay development. The position will require an individual with strong analytical, leadership and communication skills (both written and oral) and the ability to work both independently and in a cross functional setting.
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.
Celularity is a leading clinical stage NJ-based biotechnology company in cellular therapeutics. The Translational Research group is seeking a highly motivated Senior Scientist to design and evaluate gene modifications to enhance Celularity’s allogeneic placental NK cell and T cell therapeutic platforms in immune oncology. The candidate will have 3+ years of postgraduate academic or pharmaceutical industry experience in the field of NK, T cell and/or hematopoietic stem cell biology. Expertise with retroviral or lentiviral methods of transgene expression in lymphocytes is required. Prior experience with the design and functional assessment of chimeric antigen receptors (CAR) is required. The candidate will regularly collaborate with internal and external research teams to identify targets of interest, design, and execute proof of concept studies. The candidate will also work with clinical, legal and business development teams to initiate new product development and strategy.
Celularity is seeking an experienced dynamic individual to lead a motivated team of clinical operators and manage the daily manufacture of multiple cell therapy products in support of the company’s clinical stage platforms. 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.