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Cresilon

Plant-based hemostatic gel for bleeding control

Director of Research & Development

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeBrooklyn, NY, USA$160k - $240k /yr

About the Job

Requirements

  • A bachelor’s degree in Chemical Engineering, Materials Science & Engineering, Mechanical Engineering, Biomedical Engineering, Chemistry, or a related discipline.
  • At least 10 years of direct management experience, including the ability to attract, assess, hire, develop, and manage engineers, scientists, and technicians, and influence, motivate, and drive technical rigor.
  • At least 10 years of experience developing and using polymer materials, chemistries, or other complex materials for product or application development and manufacture.
  • Demonstrated success leading projects from early development through stage-gate milestones, regulatory submission, and commercial launch.
  • Experience developing and commercializing products in a highly regulated environment.
  • Hands-on research experience with materials chemistry, polymers, adhesives, coatings, biomaterials, naturally derived materials, and other complex systems, including developing structure-property-performance relationships in the design and characterization of these materials.
  • Demonstrated experience in project management and product lifecycle management practices, with the ability to lead multiple projects simultaneously.
  • Strong project management and change management leadership skills.
  • Strong problem-solving and analytical skills.
  • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet application requirements, with a fundamental understanding of the chemistry driving required performance; strong analytical, problem-solving, and decision-making skills, and the ability to observe and think creatively.
  • Excellent written and verbal communication skills to influence cross-functional and senior stakeholders.
  • Track record of cross-functional and cross-disciplinary collaboration with R&D, Manufacturing, Regulatory, Quality, and Commercial teams in fast-paced environments.
  • Ability to identify and lead improvement initiatives, coach and train individuals, and stimulate innovation.
  • Ability to identify and analyze complex technical problems and implement innovative solutions.
  • Strong leadership and organizational skills, attention to detail, and multitasking skills while maintaining an overall view of projects, priorities, and strategies.
  • Experience working under pressure with tight timelines while maintaining priorities, focus, urgency, and delivery.
  • Strong working knowledge of Microsoft Office, Microsoft Excel, Microsoft Word, and Microsoft PowerPoint.
  • Legal authorization to work in the United States.
  • Ability to obtain appropriate vaccinations and clearance to work in an operating room or surgical environment; work in a laboratory environment; wear appropriate personal protective equipment; sit and stand; perform normal office and laboratory work for moderate periods; and speak, listen, and understand verbal and written communication.

Responsibilities

  • Lead, staff, and manage the R&D team across multiple parallel product development opportunities to launch commercially successful products and processes in animal health and human markets.
  • Provide scientific leadership, support, and coaching to the R&D team through the initiation, planning, execution, and monitoring of its activities.
  • Oversee discovery and innovation efforts focused on materials and technologies, providing technical expertise and scientific direction to ensure new product development and sustaining engineering projects meet committed schedules, specifications, and budgets.
  • Lead technology transfer, scale-up, process characterization, and validation by coordinating transfers and providing technical assistance for introducing new products and processes into manufacturing operations.
  • Serve as a subject matter expert for short- and long-term growth strategy across R&D sub-departments, facilitating efficient resource use and aligning personal and project goals with company goals.
  • Lead exploratory research and development to support pipeline expansion goals.
  • Interface regularly with the Vice President of Technology to ensure research operations reflect the corporate vision and strategy.
  • Ensure compliance with applicable specifications, standard operating procedures, and FDA regulations.
  • Ensure budgets, schedules, and performance requirements are met.
  • Collaborate with stakeholders, functional managers, and cross-functional staff to facilitate project execution, resolve conflicts, and remove obstacles.
  • Develop and implement investigations into new technologies and capabilities that advance research team and company objectives.
  • Provide technical assistance in diagnosing design and manufacturing quality problems.
  • Guide development and documentation of test plan protocols, standard operating procedures, specifications, and test procedures.
  • Review and provide functional approval for project and quality-system documentation.
  • Maintain positive and cooperative communication and collaboration with employees at all levels, customers, contractors, and vendors.
  • Perform other related duties and responsibilities as assigned.
  • Work with a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and assessments.
  • Ensure an effective documentation system is used throughout development, including R&D lab notebooks, design reviews, test methods, and test reports.
  • Attract, retain, and develop scientific and engineering technical staff, ensuring technical know-how is shared and continuously increased within the R&D team.
  • Develop unique, proprietary, ideally patentable intellectual property that provides competitive advantage.
  • Lead research department reviews and other team meetings, develop agendas, handle reviews, and follow up on action items.
  • Improve efficiency and optimize research operations through implementation of stage-gate process infrastructure.
  • Administer and manage Cresilon grant, SBIR, and other non-dilutive funding activities.
  • Lead efforts to publish research in peer-reviewed journals.
  • Develop and implement administrative tools to support effective communication among research staff.
  • Develop test-method capabilities to support R&D and production testing requirements.
  • Validate current and future testing methodologies as a subject matter expert in experimental design.

Desired Qualifications

  • A Ph.D. in a relevant discipline is strongly preferred.
  • Experience leading product device design and development of regulated medical devices and delivery system platforms from initial concept through market release.
  • Strong working knowledge of design controls for medical and/or combination product and device development.
  • Strong knowledge of product development lifecycle, risk management, and quality systems.
  • Working knowledge of medical regulatory requirements for Class II and III medical devices, including 21 CFR Part 820, cGLP/cGMP, and related standards such as ISO 13485.
  • Experience with combination products or biologic interfaces.
  • Strong understanding of cGMP and ICH guidelines.
  • Demonstrated experience in project management and product lifecycle management practices for large-scale projects.
  • Experience executing grant and publication submission strategies, and knowledge of and a strong track record with SBIR submissions to multiple agencies, including NIH and DOD.
  • Prior experience implementing continuous improvement in product development and manufacturing practices.
  • Six Sigma green belt or black belt certification.

About the Company

Cresilon

Plant-based hemostatic gel for bleeding control

Cresilon makes medical devices that stop bleeding with a plant-based adhesive gel. Its main product, VETIGEL, is a fast-acting gel designed to control bleeding in veterinary patients, and Cresilon serves human trauma and surgical markets as well. The gel is applied to a wound and works to seal and promote clotting within seconds without needing manual pressure. Cresilon differentiates itself by offering a gel-based hemostat and by being among the first to target veterinary applications with a rapid, easy-to-use solution, along with direct sales and partnerships (for example, the VerticalVet Preferred Partnership) to reach clinics and hospitals. The company’s goal is to broaden the gel technology’s uses to improve wound care and save lives across veterinary, human trauma, and surgical settings.

Company size
51-200
Company stage
Early VC
Total funding
$116.5M
Headquarters
New York City, New York
Founded
2010

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