Preclinical Operations Supervisor

Johnson & Johnson Innovative Medicine•Cincinnati, OH

2d•$109,000 - $174,800•Onsite

About The Position

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. 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 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.

Requirements

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 surgical methods is desired
Proficiency with Microsoft 365 applications, including Word, Excel, PowerPoint, and Copilot is required
Ability to work independently and as part of a project team
Proven organizational and time management skills are essential

Nice To Haves

Analytical Reasoning
Data Management and Informatics
Developing Others
Epidemiology
Ethical and Participant Safety Considerations
Inclusive Leadership
Laboratory Operations
Laboratory Safety
Leadership
Mental Agility
Molecular Diagnostics
Motivating People
Process Improvements
Quality Assurance (QA)
Regulatory Compliance
Research and Development
Team Management
Toxicology

Responsibilities

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
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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year