Preclinical Principal Scientist, Research & Development

Requirements

• DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field
• Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience
• Extensive knowledge of surgery, anatomy, toxicology, and pathology is required
• Hands-on surgical experience is required
• Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations
• Strong communication skills (both written and verbal) are 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
• Excellent problem-solving, conflict resolution, and analytical skills
• 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
• Requires strong leadership and organizational skills, including attention to detail and multi-tasking skills
• Able to understand and execute to project details while keeping overall “big picture” view of projects, priorities, and strategies
• Must be able to stand, walk and maintain static positions for extended periods while performing laboratory, vivarium, and surgical procedures
• Requires excellent hand-eye coordination, fine motor skills, and manual dexterity to perform preclinical surgeries and operate laboratory equipment
• Must be able to visually assess animals, surgical sites, experimental outcomes, and laboratory data, including close-up and detailed observations
• Must be able to lift and move materials and equipment up to 50 pounds occasionally, and frequently bend, reach, stoop, kneel, and maneuver within laboratory and animal research environments
• Must be able to wear required personal protective equipment (PPE), work safely with biological materials and research animals, maintain visual acuity for detailed observations, and obtain any required occupational health clearances and vaccinations
• Must be able to work with biological materials, chemicals, and pharmaceutical or medical device products in accordance with applicable safety procedures
• Legal authorization to work in the United States

Nice to have:

• 4+ years of people management experience
• Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices
• Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects
• Experience with surgical publication submission strategy
• Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities
• Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements
• Good Laboratory Practices (GLP) experience 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
• Hands-on research experience with hemostatic devices and/or coagulation chemistry

Benefits

• 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
• 401(k) & Roth Retirement Savings Plan with company match up to 5%
• Monthly NYC MetroCard Reimbursement

Important Details

• Work format: hybrid (off-site at CRO in the NY area, work from home, and on-site at Brooklyn, NY)
• Travel: up to 30% (to monitor and execute out-sourced studies)

About the Company

Cresilon is a Brooklyn-based biotechnology and medical device company that develops, manufactures, and markets hemostatic products. The company is driven by a mission to save lives, powered by proprietary plant-based hydrogel technology. Cresilon's current commercial portfolio includes TRAUMAGEL® for human trauma and VETIGEL® for veterinary applications, with planned expansion into human surgical applications and beyond.