ManagerPrincipal Scientist Research & Development Polymer Formulation Devices

Cresilon is a Brooklyn-based biotechnology company that develops manufactures and markets hemostatic medical devices utilizing the companys proprietary hydrogel technology. The companys plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The companys current and future product lines target veterinary human trauma and human surgical applications. Cresilons mission is to save lives. Learn more about the company at .

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 companys 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 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 teams 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 tosupport Cresilons business objective.

Required Qualifications

• Masters 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 are 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 an 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 $130000 - $180000 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%

Required Experience:

Manager