Cresilon, Inc.

Cresilon, Inc.

Manager/Principal Scientist Research & Development - Polymer Formulation Devices

Brooklyn, New York, United States · Principal · Full-time

Sponsorship not specified$130k-$180kDetected 44 days ago
A/B TestingProduct ManagementProject ManagementBusiness DevelopmentProcess ImprovementIntellectual PropertyGMPFDA RegulatoryMedical DevicesResearchExperimental DesignLeadershipCommunicationProblem SolvingMentoringPublic SpeakingAdaptabilityOrganizational SkillsRegulatory Affairs

About the role

  • 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.
  • Learn more about the company at www.cresilon.com.

Responsibilities

  • In 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.
  • Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products.
  • Create and lead experimentation of exploratory and/or product development research with a focus on polymeric materials and their use.
  • 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.

Requirements

  • Master's degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline.
  • A minimum of 2 years of direct management experience.
  • 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.
  • Strong working knowledge of Microsoft Office.

Nice to have

  • Ph.D. in a relevant discipline is strongly preferred.
  • 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.
  • 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.
  • Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Compensation

  • $130k-$180k

Benefits

  • Cresilon ® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology.
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