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Job Description 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 . The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME) and Project Manager in the execution of Cresilon’s Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. This position as a hybrid role, with work off-site at CRO in NY/NJ area, work from home and on-site at Brooklyn NY. Job Responsibilities: The Preclinical Research Scientist will: • Lead, staff, and manage Cresilon’s Preclinical Research activities., • Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle., • Plan, direct, coordinate and execute activities related to the design, initiation and follow-up of studies to support approval of Class I-III medical devices., • Develop, write, and/or review study protocols and reports. Act as technical mentor for the development of study experimental designs, protocols, and reports of junior associates., • Administrate and manage Cresilon preclinical regulatory strategy and communication., • Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites., • Ensure that company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon., • Be a Subject Matter Expert (SME) for preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state of the art knowledge., • Oversee the development of and modifications to preclinical models to address project needs., • Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines., • Surveys the literature to identify and compare competitive product performance and safety risks., • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc), • Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary., • Manage budgetary requirements for all research projects to support efficacy and safety programs., • Lead the effort to publish surgical research in peer-reviewed journals., • Regularly interface with management to ensure research operations reflect overall corporate vision/strategy., • DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience., • 4+ years of people management experience preferred., • Extensive knowledge of surgery, anatomy, toxicology, and pathology is required., • Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred., • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred., • Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations., • Experience with surgical publication submission strategy is strongly preferred., • Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management., • Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required., • Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred., • Excellent problem solving, conflict resolution, and analytical skills is required., • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required., • Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required., • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills., • Able to understand and execute to project details but keep overall “big picture” view of projects, priorities, and strategies is required., • Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred., • Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP), • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred., • Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred., • Legal authorization to work in the United States., • This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies) 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 - $210,000, depending upon job level and 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%

Job DescriptionCompany Overview:Established in 1805, the New York City Department of Health and Mental Hygiene (the NYC Health Department) is the oldest and largest health department in the country. Our mission is to protect and improve the health of all New Yorkers, in service of a vision of a city in which all New Yorkers can realize their full health potential, regardless of who they are, how old they are, where they are from, or where they live. As a world-renowned public health agency with a history of building transformative public health programming and infrastructure, innovating in science and scholarship to advance public health knowledge, and responding to urgent public health crises — from New York City’s yellow fever outbreak in 1822, to the COVID-19 pandemic — we are a hub for public health innovation, expertise, and programs, and services. We serve as the population health strategist, and policy, and planning authority for the City of New York, while also having a vast impact on national and international public policy, including programs and services focused on food and nutrition, anti-tobacco support, chronic disease prevention, HIV/AIDS treatment, family and child health, environmental health, mental health, and racial and social justice work, among others. Job Summary:The Bureau of Data Technology and Strategy seeks a Data Science Associate to provide technical support for the application of data science to study public health outcomes and solutions. The Data Science Associate will engage in the implementation of AI/ML research tools, bringing in-house solutions to scale, and adapting developed technologies to new use cases. Problem-solving and stakeholder engagement skills will be applied in the public health setting to facilitate research, advanced analytics, and operations. The Data Science Associate will regularly interface with data engineers, data product developers, and data governance staff to integrate and maintain novel solutions into an enterprise data platform. The Data Science Associate will provide technical assistance to Agency users to promote and maintain the use of AI/ML technology solutions. The Data Science Associate will also provide support to the Senior Research Data Scientist for proposal development including technical advisement on analytic approaches and methods, technology resource requirements, timelines, and intended outputs. The successful candidate will be situated within a values-driven and highly collaborative work unit with strong technical and professional mentorship; professional development opportunities will be continuously available. This position will be within the Health Department’s innovative Center for Population Health Data Science (CPHDS). The CPHDS is working to strengthen citywide population health surveillance by better linking public health, healthcare, and social service data to fully characterize and improve the health of New Yorkers. Our vision is for these data tobe accessible, timely, equitable, meaningfully usable, and protected – and being actively to protect and promote health and wellbeing of New Yorkers. The selected candidate will be an employee of Public Health Solutions, a nonprofit organization which is the fiscal and administrative manager of the grant, but the work be supervised by DOHMH. This position will be based at the Health Department’s office in Long Island City, NY, with the possibility of hybrid work. Responsibilities: • Support research that strengthens public health insights and actions through the use of data scientific methods, especially reusable, scalable AI/ML methods, • Identify and/or assist development of AI/ML methods and/or practices; promote them to agency’s data analysts, data engineers, data scientists, and researchers through trainings and/or reports, • Contribute to development of health equity-focused data products, • Collaborate with CPHDS data engineers, product developers, product managers, and researchers to develop and launch public health analytic solutions for the Agency and the public health community at-large, • Collaborate with internal and external researchers and analysts for various research projects, • Author reports, presentations, and scientific papers based on analyses Qualifications:, • A minimum of 2 years of work experience in statistical learning development, with some work experience in the development of deep learning algorithms, • High fluency in the Python programming language is required, with proficiency in one of the deep-learning frameworks PyTorch or Tensorflow, • Experience in virtualization technology, particularly with working experience in cloud environments (e.g., Azure, GCP, AWS, Databricks), • Experience in the development and deployment of foundation models, • Advanced knowledge and experience in data wrangling, analysis, and visualization, • Knowledge of public health research and operations, including health equity, • Experience developing user interfaces and dashboards, working with geospatial data a plus, • Ability to work with staff at all levels and to communicate complex technical knowledge in language that is understood at every level, • Hybrid Work Schedule., • Generous Paid Time Off and Holidays., • An attractive and comprehensive benefits package including Medical, Dental and Vision., • Flexible Spending Accounts and Commuter Benefits., • Company Paid Life Insurance and Disability Coverage., • 403 (b) + employer matching and discretionary company contributions., • College Savings Plan., • This individual must reside in the tri-state area (NY, NJ, CT) by their confirmed start date., • Preference may be given to individuals residing in New York City (5 boroughs) or surrounding New York State counties., • This individual will be expected to work non-business hours during emergencies., • This is a temporary grant-funded position ending in November 2027 At PHS, we place immense value on diversity within our teams, understanding that varied backgrounds and experiences significantly enhance our community and propel us toward our goals. If you find you don’t have experience in all the areas listed above, we still encourage you to apply and share your background and experiences in your application. We are eager to discover how your unique perspective can bring positive transformations to our team and help advance our mission of creating healthier, more equitable communities. We look forward to learning more about you! PHS is proud to be an equal opportunity employer and encourages applications from women, people of color, persons with disabilities, LGBTQIA+ individuals, and veterans. Monday-Friday Hybrid 35 Hours Per Week

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Comprehensive health, dental, and vision insurance.

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Employer-sponsored health plan.

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Works with Quality, Environmental, Health & Safety committee to ensure and maintain compliance with safety operational, and regulatory standards.

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Health & dental insurance coverage.

Looking for a project manager with 5 + years' experience.Responsible for end-to-end management and delivery of a material change for a project of high complexity across multiple departments across multiple business units.Manages, leads and directs the work efforts of resources that may be functional

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