Sr. Research Associate, Medical Devices, Research & Development

Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and cryopreserved allogeneic cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placentas unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com .

The Senior Research Associate is responsible for day-to-day analytical/biophysical testing and process development activities, supporting the companys product development and commercial needs. This position will play a key role in the development and validation of innovative placenta-derived biomaterial medical devices or cell-based products, contribute to cross-functional R&D efforts driving regulatory submissions and operate at the interface of biomaterials, process development, product testing, and regulatory compliance to ensure robust product performance.

This role involves developing and validating analytical/biophysical assays and testing product prototypes in compliance with regulatory requirements and industry standards. Furthermore, this role will conduct process development, validation, documentation and transfer to manufacturing activities relevant to medical devices, cell therapy or exosome products.

• Participate in development, execution, and validation of analytical and biophysical assays for prototype testing and design verification in compliance with quality requirements and regulatory guidelines.
• Perform precise manual lab techniques, data capture, and advanced statistical analysis.
• Operate, calibrate, and log maintenance of sophisticated biophysical equipment.
• Conduct process development activities related to medical devices, cell therapy or exosome products, including process development, validation, documentation and process transfer.
• Author and maintain key documentation such as test method development protocols, validation protocols, technical reports, and presentations.
• Share results with cross-functional teams and contribute to regulatory filing documentation.
• Plan and execute Design of Experiments (DOE) studies for method robustness and process characterizations.
• Work in a collaborative, multidisciplinary environment with opportunities for technical leadership, publications, patent filing, and quality and regulatory engagement.
• Ensure proper operation and performance of routine biophysical testing equipment; Completion of multiple equipment logbooks is required.
• Consistently perform various manual laboratory duties and techniques on time sensitive materials with accurate and precise manipulations and data recording.
• Excellent verbal and written communication skills as well as strong focus and attention to details are required.

Skills/Knowledge Required / Desired :

• Degree in the biological sciences; B.S. in Bioengineering, Biology, or related discipline with 1-3 years experience or equivalent industry work experience.
• Hands-on expertise in assay development, cleanroom aseptic techniques, and equipment operation (e.g., Instron, Mark-10, bioreactors, flow cytometry, spectrometry etc.).
• Strong data analysis capabilities (Excel, JMP, Prism).
• Ability to develop detailed protocols and generate batch records supporting process development and transfer activities.
• Independent troubleshooting and optimization of lab methods and processes.
• Familiarity with Design of Experiments, and process characterization.
• Demonstrated hands on aseptic techniques related to bioprocess development and process transfer to manufacturing.
• Familiarity with gowning procedures for clean room/aseptic manufacturing is required.
• Attention to detail and reporting any unexpected findings during testing and processing.
• Strong interest and passion for innovation and development of life saving products.
• Organizational and time management skills.
• Problem-solving for assay development/validation and process development.
• Dynamic personality with strong intellectual curiosity and the ability to communicate and engage others.
• Independent and self-starting.
• This position may require occasional travel to external partners.
• The work environment includes office, research laboratory, and pilot-scale cGMP manufacturing settings.