Manager/Principal Scientist Research & Development - Polymer Formulation Devices

About the Company

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.

Responsibilities

• Lead, staff, and manage formulation development teams across multiple product development opportunities
• Provide scientific leadership, monitoring, and coaching for team activities
• Create and lead experimentation for exploratory and product development research focused on polymeric materials
• Lead material, design, and process changes through the design control process
• Review and author protocols and reports, including development studies and design verification/validation
• Develop unique, proprietary intellectual property to yield competitive advantage
• Interface with customers, suppliers, and cross-functional teams to develop specifications
• Maintain active dialogue with Regulatory Affairs and Manufacturing to ensure successful technology transfer
• Communicate research results to the scientific community via publications and symposia

Requirements

• Master’s degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or equivalent
• Minimum 10 years of research experience in polymeric materials or biomaterials
• At least 5 years of research experience in a non-academic setting
• Minimum 2 years of direct management experience
• Hands-on research experience with polymers and coagulation chemistry
• Experience in new product development from concept to regulatory approval
• Ability to design experiments and analyze data using statistical methodologies
• Legal authorization to work in the United States

Preferred Qualifications

• Ph.D. in a relevant discipline
• Experience developing and commercializing products in a highly regulated environment
• Medical device development experience
• Expertise in material characterization techniques (rheological, thermal, mechanical, spectroscopic)
• Understanding of Class II and III medical device regulatory requirements (21 CFR Part 820, ISO 13485)
• Six sigma green belt or black belt certification
• Track record with SBIR submissions to agencies like NIH and DOD