Manager/Principal Scientist Research & Development - Polymer Formulation Devices

Cresilon ® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company’s current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon’s mission is to save lives. Learn more about the company at www.cresilon.com. The R&D Manager/Principal Scientist – Polymer Formulation will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet applicable quality and regulatory standards. This role provides technical leadership and expertise in materials formulation development while building and optimizing internal capabilities to deliver innovative, efficient medical device and combination product solutions, aligned with the company’s long-term technical vision and pipeline of customer-focused innovations. Key responsibilities include developing and characterizing polymer material formulation solutions, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulation solutions into scalable manufacturing processes, whether in-house or through CDMOs. The role operates in a highly collaborative, cross-functional environment and requires flexibility, scientific rigor, and a strong drive to explore and implement new technologies in the pursuit of robust, innovative products. This is a senior technical role overseeing a small team within a dynamic, growing organization. The R&D Manager/Principal Scientist is both a strategic leader and a hands‑on contributor. In addition to managing and mentoring staff, this individual is expected to remain actively engaged in laboratory work, directly contributing to experimental design, execution, troubleshooting, and data interpretation. This role requires a player‑coach mindset, with the ability to balance people leadership, technical oversight, and individual scientific contribution. The role demands a high degree of ownership and adaptability, with the expectation that the individual will work at multiple levels—from setting technical direction to performing bench‑scale formulation development and characterization activities as needed to meet program timelines. The R&D Manager / Principal Scientist will serve as a subject matter expert in polymer materials science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for upholding high standards in research practices and ensuring scientific and technical rigor across all development activities. Additionally, they are responsible for leading the development of documentation required for regulatory submissions (e.g., 510(k), IDE, technical files), driving strategy for publications and grant applications, securing non‑dilutive funding through grant opportunities, and supporting technology transfer into manufacturing environments. They will report to the Vice President of Technology. This is a full‑time, on‑site position, located in Brooklyn, New York.

Experience developing and commercializing products in a highly regulated environment Medical device development experience Demonstrated expertise in the use, development, and qualificication of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485) Strong understanding of cGMP, ICH guidelines Six sigma green belt or black belt certification Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously Excellent problem‑solving skills and a proactive approach to addressing formulation challenges Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.