Preclinical Operations Supervisor

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: R&D Operations

Job Sub Function: Laboratory Operations

Job Category: People Leader

All Job Posting Locations: Cincinnati, Ohio, United States of America

Job Description: About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of MedTech surgery? Ready to join a team that’s reimagining how we heal? Our MedTech Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://jnjmedtech.com

Johnson and Johnson’s Robotics & Digital Solutions division (RAD) is searching for the best talent for a Preclinical/Laboratory Operations Supervisor role located in Cincinnati, OH. This is a fully on-site position.

Purpose: Robotics & Digital Solutions is part of J&J MedTech, a global leader in surgery with products and solutions found in almost every operating room around the world. J&J MedTech has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through J&J MedTech’s surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.

This is a hands-on role within the Preclinical team and represents an outstanding opportunity to work cross functionally with various groups that utilize the Preclinical Labs. Supervision, assistance, and support in this space will be essential to the development of J&Js highly innovative Ottava robotic and digital surgery platform. This position will also support the development of technical documents for Preclinical studies that inform J&Js regulatory submissions and evidence-generation strategies.

You will be responsible for:

Key Operations • Overall supervision and coordination of RAD Preclinical Operations activities in Cincinnati • Organizing, managing, and supporting various surgical laboratory research studies and research activities •  Management of surgical laboratory supplies, tools, robotic instruments, inventory and distribution in compliance with regulatory requirements and organizational procedures • Provide oversight and direction to lab operations staff, including planning team meetings • Management of vendor accounts and fostering relationships for ongoing surgical laboratory needs • Management of cadaveric tissue and biohazardous waste • Promoting environmental health and safety compliance in our labs per company policies • Manage review and revision of relevant lab SOP’s on a quarterly basis or as necessary • Ensure lab maintenance and instrumentation cleanliness/sterility in compliance with regulatory requirements and organizational procedures • Ensure proper documentation and record keeping in compliance with regulatory requirements and organizational procedures

Key Technical Writing Skills • Support developing, reviewing, and finalizing a wide range of scientific and regulatory documents including, but not limited to, scientific protocols and reports, post-operative evaluations, Quality audit edits and responses, responses to regulatory agencies, and IACUC documents. • Perform literature searches to support research activities, IACUC documentation, and publications. • Ensure all documentation complies with current regulatory standards, industry guidelines, and internal SOPs. • Support change management activities. • Foster strong, collaborative relationships with cross-functional teams including R&D, Regulatory Affairs, and Quality Assurance.

Qualifications / Requirements:

Required: • Bachelor’s degree in a a related domain • Minimum of 3 years of relevant scientific experience, with a strong background in preclinical, medical, and/or clinical research or related fields • Knowledge of GLP requirements • Excellent oral and written communication skills with a keen eye for detail. • Strong leadership and project management skills, including influencing, negotiating, and problem-solving. • Demonstrated learning agility and ability to adapt to evolving technologies and regulatory landscapes. • Experience with IACUC regulations, scientific experimental design, and protocol development • Familiarity with 510(k) documentation and submission processes • Copy editing, proofreading, and data synthesis skills • Understanding of SOPs, research ethics, and quality standards • Understanding of human/animal anatomy and surgica

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