Senior Scientist, Process Development (Medical Devices)

Celularity Inc. (Nasdaq: CELU) is a regenerative medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells.

We are seeking a highly skilled and motivated Senior Scientist to lead process development activities for medical device programs, including those pursuing 510(k) regulatory submissions. This role is critical in driving the development, optimization, validation, and transfer of manufacturing processes from R&D to manufacturing.

The ideal candidate will bring strong technical expertise, regulatory knowledge, and a collaborative mindset to ensure the successful delivery of innovative medical devices to market. The successful individual will demonstrate subject matter expertise in preparation of regulatory documents, including pre-RFD, Q-submission, 510(k) dossier etc. The position will require an individual with strong scientific leadership and communication skills (both written and oral) to work with project teams across the functional departments.

• Design, develop, and optimize robust, scalable, and reproducible manufacturing processes for medical devices.
• Evaluate and implement innovative technologies to improve process efficiency, scalability, and compliance.
• Lead process validation efforts to meet regulatory standards (e.g., FDA 21 CFR Part 820).
• Develop validation protocols, execute studies, and generate comprehensive validation reports.
• Collaborate with Quality and Regulatory Affairs departments to provide technical documentation and justifications for 510(k) submissions.
• Ensure all processes and documentation align with FDA, ISO 13485, and other applicable regulations.
• Lead the seamless transfer of processes from R&D to manufacturing, ensuring scalability and consistency.
• Provide hands-on support during pilot production and commercial scale-up.
• Work closely with R&D, Quality, Regulatory, and Manufacturing teams to align process development activities with overall program goals.
• Support risk assessments, design reviews, and failure mode and effects analysis (FMEA) for processes.
• Investigate and resolve technical challenges related to process performance, yield, and quality.
• Identify and implement process improvements to drive efficiency, reduce costs, and enhance product quality.
• Participate in the management of external collaborations and CROs.
• Manage or coordinate the workflow on assigned projects.
• Provide written and oral scientific progress reports to Project Lead and Executive Management, generate intellectual property applications and scientific publications.
• Maintain laboratory records, electronic files, and laboratory notebooks to support experimental studies and intellectual property development.
• Assist team members as necessary to complete divisional goals.
• Maintain a safe and clean work environment in accordance with lab/OSHA policies/procedures.

Skills/Knowledge Required / Desired:

• Ph.D. in Biomedical Engineering, Chemical Engineering, Materials Science, or a related field with 5 years of relevant experience.
• Proven track record in process development for medical devices, preferably involving 510(k) regulatory submissions.
• Strong expertise in process validation methodologies.
• Hands-on experience with technology transfer from R&D to manufacturing.
• Comprehensive knowledge of FDA regulations (e.g., 21 CFR Part 820) and ISO 13485 standards.
• Strong problem-solving skills with the ability to troubleshoot complex technical challenges.
• Proficiency in statistical tools and risk analysis techniques (e.g., FMEA).
• Documented familiarity with the content generation of Design History Files.
• Strong expertise related to the development of advanced biomaterials, cellular products and combination of biomaterials and cells.
• Highly detail-oriented, organized, and capable of managing multiple projects simultaneously.
• Demonstrated leadership in cross-functional teams and ability to mentor junior team members.
• A results-driven mindset with a strong commitment to innovation and quality.
• Experience in bioanalytical, biophysical characterization, viral inactivation strategies and testing of medical devices or combination products is preferred.
• Experience in writing study protocols, reports, regulatory filings, and scientific publications.
• Track record of success as evidenced by impactable contributions in biomedical and biopharmaceutical cross-functional settings is preferred.
• Effective communication is essential and includes presentations to clearly convey scientific concepts and data among research scientists, management teams within internal working groups/project teams, external academic and industrial organizations, review committees, and conferences.
• Must be a team player, able to collaborate across the enterprise.

This position may require occasional travel to external partners.

The work environment includes office, research laboratory, and pilot-scale cGMP manufacturing settings.