R&D Manager/Principal Scientist - Polymer Formulation

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.

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 levelsfrom 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.

Responsibilities

• Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products.
• Provide sound scientific leadership, monitoring, and coaching through the initiation, planning, and execution of their team's overall activities.
• Create and lead experimentation of exploratory and/or product development research with a focus on polymeric materials and their use.
• Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures.
• Lead material/design/process changes through the design control process, with well-documented research/analyses.
• Review and author protocols and reports, including development studies and design verification/validation activities.
• Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance the research team and company objectives.
• Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements.
• Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage.
• Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies.
• Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication.
• Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments.
• Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports.
• Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions.
• Act as research liaison between R&D and Quality Control to define product specifications.
• Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents.
• Provide guidance and support to commercial teams, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data.
• Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company.
• Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization.
• Provide other project, product, or leadership support as needed to support Cresilon's business objective.