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. Learn more about the company at www.cresilon.com.

The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company's long-term technical vision to create a strong pipeline of customer-focused innovations.

Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products.

The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President 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 their team's overall activities.
• Create and lead experimentation for exploratory and/or product development research with 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 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 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 introduction of new technologies with 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.