Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing proprietary hydrogel technology. The company's plant-based technology rapidly stops traumatic and surgical bleeds without manual pressure. Current and future products target veterinary, human trauma, and surgical applications. Cresilon's mission is to save lives. Learn more 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 medical devices, ensuring compliance with quality and regulatory standards. This role involves expertise in formulation development, building internal capabilities, and aligning with the company's long-term technical vision to create a pipeline of innovations.
Key responsibilities include developing formulations, recruiting talent, managing collaborations with suppliers, and integrating formulations into scalable manufacturing processes, whether in-house or via CDMOs. The role requires collaboration across teams, flexibility, scientific focus, and a drive for technological advancement in materials and products.
The ideal candidate is an expert in polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions. Responsibilities include preparing documentation for regulatory submissions, developing grant and publication strategies, and securing funding through grants. The position reports to the Vice President of Technology.
This is a full-time, on-site role based in Brooklyn, NY.
Responsibilities
- Lead formulation development teams across multiple projects to launch successful products.
- Provide scientific leadership, coaching, and oversight of team activities.
- Design experiments focused on polymeric materials for research and product development.
- Make technical judgments in experiment design, execution, and interpretation, solving complex problems creatively and scientifically.
- Manage material, design, and process changes through documented design control processes.
- Review and author protocols, reports, and validation activities.
- Investigate new technologies to support research and company goals.
- Evaluate chemical and mechanical properties to inform process or formulation changes and develop testing methods.
- Create proprietary, potentially patentable intellectual property to maintain competitive advantage.
- Participate in VOC labs and influence go-to-market strategies.
- Coordinate with customers, suppliers, and internal teams to develop specifications and prototypes.
- Develop, verify, and validate product designs through various testing methods.
- Maintain thorough documentation throughout the development process.
- Collaborate with Regulatory Affairs on documentation for FDA and other regulatory submissions.
- Act as a research liaison with Quality Control and Manufacturing for product specifications and technology transfer.
- Support commercial teams with technical presentations, formulations, and application data.
- Publish research findings, present at industry and academic forums, and represent the company externally.
- Contribute to a culture of ethical, high-quality research practices.
- Provide additional support to projects and leadership as needed.
Requirements
- Bachelor’s in Chemistry, Material Science, Chemical Engineering, Polymer Science, or related field.
- At least 2 years of management experience.
- Minimum 10 years of research experience in polymeric or biomaterials development for products and manufacturing.
- Hands-on experience with polymers, chemistries, and structure-property relationships.
- Proven problem-solving skills and practical solution delivery.
- Experience from concept to regulatory approval and product launch.
- Ability to design experiments and analyze data with statistical rigor.
- Excellent communication skills and ability to lead in a collaborative environment.
- Strong organizational skills and attention to detail.
- Leadership experience, including mentoring and resource management.
- Ability to work under pressure and meet tight deadlines.
- Proficiency in Microsoft Office.
- Legal authorization to work in the U.S.
Preferred Qualifications
- Ph.D. in a relevant discipline.
- Experience in regulated medical device development.
- Expertise in material characterization techniques.
- Knowledge of medical device regulations (e.g., 21 CFR Part 820, ISO 13485).
- Six Sigma certification.
- Experience with grants, publications, and SBIR submissions.
- Project and product lifecycle management expertise.
Equal Opportunity Statement
Cresilon is an equal opportunity employer committed to a diverse workplace. We prohibit discrimination based on protected characteristics as outlined by law. Employment decisions are made based on qualifications, merit, and business needs.
Benefits
- Competitive salary range: $130,000 - $180,000.
- Paid vacation, sick leave, and holidays.
- Medical, dental, vision, FSA, and commuter benefits.
- Company-paid life and short-term disability insurance.
- Employee assistance program.
- MetroCard reimbursement.
- 401(k) and Roth retirement plans with company match up to 5%.