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.
This is a senior technical role overseeing a small team. 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.
Required Qualifications
- Master’s degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline.
- A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture, with at least 5 years in a non-academic setting.
- A minimum of 2 years of direct management experience.
- Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials.
- Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively.
- Direct experience in new product development from concept to regulatory approval through launch.
- Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required.
- Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required.
- Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required.
- Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities.
- Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall “big picture” view of projects, priorities, and strategies.
- Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery.
- Strong working knowledge of Microsoft Office.
- Legal authorization to work in the United States.
Preferred Qualifications
- Ph.D. in a relevant discipline is strongly preferred.
- 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.
BENEFITS
- Competitive annual base salary range of $130,000 - $180,000, depending upon qualifications.
- Paid Vacation, Sick, & Holidays
- Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
- Company Paid Life and Short-Term Disability Coverage
- Work/Life Employee Assistance Program
- Monthly MetroCard Reimbursement
- 401(k) & Roth Retirement Savings Plan with company match up to 5%